Canada Gazette, Part I, Volume 152, Number 43: Safety of Sperm and Ova Regulations

October 27, 2018

Statutory authority

Assisted Human Reproduction Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Executive summary

Background

Canadians are increasingly using assisted human reproduction (AHR) — such as in utero insemination and surrogacy — to help them have children and build their families. ^{footnote 1}, ^{footnote 2} This trend is driven by a number of factors, including infertility among heterosexual couples, ^{footnote 3} scientific advances in cryopreserving ova, and the increasing use of AHR by the LGBTQ2 community and single parents to have children. Health Canada is committed to making sure the rules governing AHR help protect Canadians' safety and reflect their needs.

In 2004, the Assisted Human Reproduction Act (the AHRA, or the Act) received royal assent. The AHRA, which was informed by recommendations from the 1993 Royal Commission on New Reproductive Technologies, ^{footnote 4} is a legislative framework that helps protect and promote the health, safety, dignity and rights of individuals who use or are born of AHR in Canada. Among the provisions of the AHRA that are in force, section 2 provides key principles that underpin the Act, including those that recognize that the health and well-being of children born of AHR technologies must be a priority in decisions related to the technology's use, and that persons who seek to undergo AHR procedures must not be discriminated against. Sections 5 to 9, which are also in force, set out prohibited activities related to AHR that may pose significant human health and safety risks, that may compromise the dignity and rights of individuals, or that have been deemed to be ethically unacceptable.

In 2010, the Supreme Court of Canada found that certain sections of the legislation exceeded the legislative authority of the Parliament of Canada under the Constitution Act, 1867 and were therefore unconstitutional. In 2012, Parliament repealed those sections, and a new prohibition was enacted in the AHRA that has as its purpose the reduction of the risks to human health and safety arising from the use of third-party donor sperm and ova for the purposes of AHR. Third-party donor sperm or ova (referred to hereafter as donor sperm or ova) is sperm or ova that has been obtained from a donor and is meant for use by a female person other than a spouse, common-law partner or sexual partner of the donor. Donor sperm or ova may be from an anonymous donor, a donor who also acts as a surrogate mother, or may be from a donor who is known to the recipient but who is not their spouse, common-law partner, or sexual partner.

Several sections of the AHRA require regulations to operate and cannot be brought into force until the regulations that make them operational have been made. In December 2007, the first such section was brought into force, concurrent with the Assisted Human Reproduction (Section 8 Consent) Regulations ^{footnote 5} (the Consent Regulations). These Regulations set out, among other things, requirements for how consent is provided or withdrawn with respect to the use of human reproductive material ^{footnote 6} or in vitro embryos (IVE). The remaining sections of the AHRA that are not yet in force would come into force by an order of the Governor in Council, and with supporting regulations concurrently made where needed. The AHRA also requires that, subject to certain procedures and exceptions, proposed regulations must be laid before each House of Parliament before the regulations are made and referred to the relevant committee in each House, and any reports they provide are to be taken into account by the Minister of Health.

The safety of donor sperm is currently regulated under the Processing and Distribution of Semen for Assisted Conception Regulations (the Semen Regulations) under the Food and Drugs Act. Any person who processes, imports or distributes donor sperm in Canada that is for assisted conception must comply with the Semen Regulations. Currently, donor ova are not subject to specific safety requirements under federal law.

The AHR industry includes, among others, sperm and ova banks, importers and distributors, fertility clinics, lawyers, consultants, surrogates, sperm and ova donors, and health care providers. The majority of donor sperm and, Health Canada believes, the majority of donor ova used in Canada for AHR are imported from the United States, where sperm and ova may be purchased from a donor. In Canada, donor sperm and ova may be purchased from a sperm or ova bank, provided that the bank is not acting as an agent or representative of the donor. However, the AHRA prohibits in Canada the purchase, offer to purchase, or advertisement for the purchase of sperm or ova from a donor or a person acting on behalf of a donor.

Issues

There are federal regulatory gaps with respect to AHR, due to the outdated Semen Regulations, and because the AHRA's provisions related to the safety of donor sperm and ova (section 10), reimbursement (section 12), and administration and enforcement (sections 45–58) are not in force. In addition, issues have been identified related to the existing Consent Regulations.

1. Safety oversight of donor sperm and ova

Donor sperm

Currently, donor sperm in Canada are subject to the Semen Regulations. The Semen Regulations were made under the Food and Drugs Act in 1996 to mitigate the risk of infectious disease transmission from the use of donor semen in assisted conception. At the time, a driver for regulatory oversight was cases of HIV transmission through donor sperm. Under the Semen Regulations, the donor screening (e.g. medical records review, physical exam, questionnaires) and donor testing (e.g. laboratory tests) requirements include screening and testing for certain infectious diseases.

There is a need to modernize the federal regulatory requirements for the safety of donated sperm. Keeping such a scheme up to date is important, as donor sperm carries a risk of transmitting disease to the recipient as well as the child conceived. Human health and safety oversight would be strengthened by adding diseases to the screening and testing requirements to reflect the increased spread of certain infectious diseases (e.g. West Nile and Zika viruses), and to make allowances for advances in testing methods.

As the Semen Regulations include out-of-date screening and testing practices, they are misaligned with U.S. and European requirements and industry standards and act as a barrier to the import of donor sperm from the United States and other jurisdictions. This is the case for infectious disease screening criteria as well as microbiological testing requirements. In addition, all test kits used to test donor specimens for the presence of infectious disease agents are required to be licensed in Canada, and as a result donor sperm that has been tested by equivalent kits licensed in other jurisdictions, but not in Canada, cannot be imported.

Oversight of donated sperm would benefit from adding donor screening requirements for genetic diseases. There are currently no such requirements in the Semen Regulations, but it is increasingly considered an industry best practice given the continued advances in knowledge of inheritable conditions. While Health Canada is not aware of any reported cases of serious genetic disease transmission through AHR in Canada, there have been cases of serious genetic diseases (e.g. cystic fibrosis, neurofibromatosis) passed onto donor-conceived children in the United States and Europe. ^{footnote 7}, ^{footnote 8}, ^{footnote 9}, ^{footnote 10} Information on a donor's known family history of genetic disease can increase the opportunities to mitigate the risk of transmitting such diseases to children born of AHR.

Internal analysis, as well as consultation with stakeholders and AHR experts, has pointed to the need to modernize the regulatory oversight of "directed donations," when the donor and the recipient know each other. Under the Semen Regulations, donors must meet all screening and testing criteria, even if they are known and chosen by the recipient to become their donor, as the Regulations do not distinguish between anonymous and directed donors. It may currently be possible to use a directed donor who would otherwise be excluded from donation through an application to Health Canada's Donor Semen Special Access Programme (DSSAP), which provides access in exceptional circumstances to sperm that has not been processed in accordance with certain requirements of the Semen Regulations. Applications are each evaluated, and, where they meet the DSSAP requirements, are provided with a special access authorization issued by the Minister of Health. The DSSAP was first put in place primarily to allow access to donor sperm donated prior to 2000, and did not originally accommodate directed donations. Recognizing that individuals wished to build their families using sperm from known donors who would otherwise be excluded from donating, Health Canada expanded the scope of the DSSAP to consider such requests. The expansion of the DSSAP, combined with considerable stakeholder feedback, identified the need to introduce a directed donation process into regulations.

Under the Semen Regulations, there are gaps in Health Canada's ability to provide health and safety oversight of the establishments participating in Canada's donor sperm supply chain. Currently, domestic donor sperm processors and importers are required to notify Health Canada of their intent to process or import for distribution before they begin their activities. This approach has presented a number of challenges. For instance, sperm distributors are not required to identify themselves to Health Canada. This gap in oversight of a section of the supply chain makes it more difficult for the Department to verify that recipients have access to donor sperm that complies with the Regulations. It also makes it more difficult for Health Canada to trace donor sperm in the event of a safety issue.

In addition, the Semen Regulations do not include a registration requirement as a prerequisite to the processing of sperm, nor is there any requirement for the processor or importer to attest to their compliance with the Semen Regulations. This leaves Health Canada with limited options for compelling processors to comply with the screening and testing requirements of the Semen Regulations. The Department can seize and prosecute for violations of the Food and Drugs Act or the Semen Regulations, but lacks the regulatory tools necessary to encourage processors to come into compliance when, for example, minor deficiencies in operating procedures are noted.

Under the current framework, the onus is on the importer to ensure that the donor sperm they are importing from foreign processors meets the requirements of the Semen Regulations. Issues identified with donor screening or testing of imported sperm are usually detected upon inspection of the importer after the import has occurred and distribution of the sperm may have already commenced. This increases the possibility that non-compliant sperm could be used in Canada before any issues are identified by Health Canada. To verify a foreign processors' compliance with the Regulations, Health Canada has to currently work through the Canadian importer and, if issues are identified, seek to influence the foreign processor to implement voluntary corrective actions.

Donor ova

To date, there are no federal regulatory requirements for the safety of donor ova, and Health Canada has no oversight over its supply chain. When the Semen Regulations were enacted in the mid-1990s, the field of ova donation was less advanced. However, as with donor sperm, donor ova used in AHR carries with it the potential risk of transmitting diseases to the recipient and the child conceived from that ovum.

Recent advancements in the field, such as ova cryopreservation technology, as well as the increased availability of donors via the Internet, have made it easier to access donor ova. This includes increased accessibility to donor ova from countries without robust safety oversight for ova donations. Potentially unsafe ova may be readily imported and made available to people in Canada, putting recipients and children born of AHR at increased risk of disease transmission. Although the Department is not aware of any reported cases of infectious disease transmission through donor ova in Canada, scientific studies have demonstrated that certain infectious disease agents can be detected in ova obtained from women infected with those diseases. This, combined with the risk of transmitting a serious genetic disease to a child born from using donor ova, compels Health Canada to take steps to mitigate potential risks to human health and safety that could result from the use of donor ova.

2. Reimbursement of expenditures permitted under the AHRA

The absence of regulations respecting reimbursements permitted under the AHRA has led to confusion for parties involved in sperm and ova donation and surrogacy arrangements. The AHRA prohibits reimbursing donors, surrogates and persons who maintain and transport IVEs except in accordance with the regulations. The reimbursement provision of the AHRA is not, however, in force. As a result, persons in Canada using AHR and who are reimbursing donors and surrogates are doing so in the absence of regulations. Health Canada provides, via fact sheets, some guidance as to what, in its view, may be reimbursed. ^{footnote 11} There has, nonetheless, been significant criticism of the absence of reimbursement regulations and the resulting lack of clarity. ^{footnote 12} Regulations are required to clarify what constitutes allowable reimbursable expenditures.

3. Administering and enforcing the AHRA

The administration and enforcement provisions in the AHRA set out a framework for enforcement activities. The power includes provisions that set out the activities that inspectors designated by the Minister of Health can undertake to verify that parties are in compliance, or to prevent non-compliance, with sections 8, 10 and 12 of the AHRA and their associated consent, safety and reimbursement regulations.

Among these activities, the AHRA gives inspectors the power to seize material ^{footnote 13} or information that they have reasonable grounds to believe is related to a contravention of the Act. Seized material or information is forfeited to the Crown if no application for restoration is made within 60 days, if an application for restoration is denied, or if the owner or the person in whose possession it was at the time of seizure consents in writing to its forfeiture. The AHRA requires a "designated officer" within Health Canada to make reasonable efforts to preserve any viable seized sperm, ova or IVE.

Before these provisions can be brought into force, regulations are needed to define the "designated officer" mentioned in subsection 52(3) and section 54, and to set out the requirements in relation to taking further measures with respect to seized sperm, ova or IVE, when the consent of the donor is impossible to obtain.

Subsection 51(1) of the AHRA sets out that a person from whom material or information was seized may apply within 60 days after the date of seizure to a provincial court judge within whose jurisdiction the seizure was made for an order to have the material or information restored, provided they send a notice to the Minister of their intention to do so. As the AHRA sets out no further details regarding this process, it is in regulations that the notice requirements would be set out.

4. Gaps in the Consent Regulations

The Consent Regulations specify the basic requirements in relation to the consent obtained from a donor for the use of human reproductive material or an IVE, as required by section 8 of the AHRA.

Currently, the Consent Regulations may unintentionally compromise the anonymity of third-party donors of reproductive material and IVEs by requiring the disclosure of information that may reveal their identity. While a temporary administrative solution is in place, regulatory amendments are necessary to fully respond to the concerns raised by sperm banks.

The Consent Regulations do not currently include a requirement for the retention of records. A fixed record-keeping period would better support compliance and enforcement in matters of consent. In addition, the Standing Joint Committee for the Scrutiny of Regulations has identified in the Consent Regulations certain provisions that warrant clarification as well as discrepancies between the French and English versions.

Objectives

This regulatory proposal would assist in reducing the risks to human health and safety that may arise from using donor sperm and ova for the purpose of AHR, including the risk of disease transmission. It would also provide clarity to stakeholders on the allowable reimbursements for certain expenditures involved in AHR, help maintain donor anonymity for persons who choose to donate on the basis of anonymity, and set out procedures and requirements regarding measures related to seized or forfeited information and material.

Description

This regulatory proposal, which would support the bringing into force of sections 10, 12, and 45 to 58 of the AHRA, would

1. establish a health and safety regulatory framework for donor sperm and ova used for the purpose of AHR;
2. set categories of allowable expenditures that may be reimbursed in relation to the donation of sperm and ova, the maintenance and transport of IVEs, and surrogacy, as well as set out requirements for the reimbursement of loss of work-related income for surrogate mothers;
3. set out procedures and requirements for measures related to information or material that is seized or forfeited under the AHRA;
4. amend the Consent Regulations to preserve the anonymity of donors, introduce a record-retention requirement, align the English and French versions of provisions, and clarify certain terms and phrases;
5. repeal the Semen Regulations and make a consequential amendment to another set of regulations that references the Semen Regulations; and
6. establish coming-into-force dates that would balance the need for increased safety oversight with the need to allow sufficient time for stakeholders to update their practices to comply with the regulations.

1. Safety of Sperm and Ova Regulations

The proposed Regulations would introduce a regulatory framework focused on reducing the risks to human health and safety arising from donor sperm and ova intended for use in AHR in Canada. This would be done through a set of requirements for establishments that conduct the activities of processing, importing or distributing donor sperm and ova, including measures related to the traceability of the sperm or ova. Health professionals, as defined in the Regulations, would be subject to limited regulatory requirements.

The proposed Regulations take a risk-based approach to the different activities conducted by persons along the supply chain for donor sperm and ova for use in AHR. This approach recognizes that the level of oversight for an activity should be proportionate to its health and safety risk level.

1.1 Establishments

An establishment is defined in the proposed Regulations to include persons that process, import, or distribute donor sperm and ova, and to exclude health professionals. Processing would include any of the following activities in respect of donor sperm or ova: performing donor suitability assessments, obtaining sperm or ova from a donor as well as preparing, identifying, testing, preserving, assessing the quality of, labelling, quarantining or storing donor sperm or ova. A health professional would not be considered an establishment, unless he or she conducts an activity beyond those listed in the definition of health professional, as described below.

Establishments would be subject to specific requirements primarily dealing with quality management related to the activities that they conduct and, as applicable, to their processing of donor sperm and ova activities.

Two types of establishments would be required to identify themselves to Health Canada: primary establishments would be required to register with Health Canada, and establishments that distribute or import donor sperm or ova would be required to notify Health Canada prior to the distribution or importation. All other establishments, which would include facilities (e.g. laboratories or clinics) that perform any processing activities such as testing or storage, would not be required to register or notify.

1.1.1 Primary establishments

Primary establishments are defined as establishments that conduct (themselves or through another establishment acting on their behalf) all of the processing activities in respect of donor sperm or ova for use in AHR in Canada. They would be responsible for ensuring that donor sperm or ova have been processed in accordance with the Regulations prior to distributing or making use of them. Considering the higher level of risk associated with their responsibilities, these primary establishments would have to register with Health Canada.

An application for registration of a primary establishment would be required to contain certain information, including the following: the applicant's name, address and contact information; a statement indicating whether the applicant proposes to process sperm or ova; a list of the processing activities that are proposed to be conducted in each building; and a statement as to whether the applicant intends to have another establishment process sperm and ova on its behalf as well as the name and address of those establishments and a list of processing activities and the buildings in which they will be conducted. In addition, an attestation signed by a senior executive officer would be required.

If the Minister of Health determines that the information in the application is complete, the Minister would be required to register the primary establishment and issue a registration number. The Minister would have the authority to refuse to register a primary establishment in certain situations, including where the Minister has reasonable grounds to believe that the information provided by the applicant was false, misleading, inaccurate or incomplete, or where the issuance of the registration could compromise human health or the safety of the donor sperm or ova. The Minister would have the power to suspend a registration, in part or in whole, without prior notice when he or she has reasonable grounds to believe that the safety of sperm or ova or human health and safety has been or could be compromised. The Minister could also cancel a registration under certain circumstances. Primary establishments would also be required to provide the Minister with an annual attestation that would include certifying that they have evidence to demonstrate that they are in compliance with the Regulations.

Registration is considered necessary to identify and monitor primary establishments, as the activities they would conduct are integral to the safety of donor sperm and ova. Given that primary establishments would need to attest to, and have evidence to demonstrate, compliance with the Regulations to maintain registration, Health Canada would be provided with the regulatory tools needed to help determine if the requirements of the Regulations are being met and to take enforcement actions if they are not.

Primary establishments would be responsible for the processing activities conducted by other establishments on their behalf. These activities could include, for instance, testing and preparing donor sperm and ova. The primary establishment would, however, always remain responsible for determining that donor sperm or ova can be released from quarantine. Establishments that conduct activities on behalf of primary establishments would not be required to register with Health Canada; primary establishments would be required to identify them in their registration applications. The establishments that perform processing activities on behalf of a primary establishment would be subject to applicable requirements related to the activities they perform on behalf of the primary establishment as well as to the requirements that apply to all establishments, and, like other establishments, they could be subject to inspection to verify compliance with the Regulations.

The current limitations on Health Canada's ability to provide safety oversight on imported sperm collected and processed in other countries would be addressed, in part, by the registration scheme and the general requirement placed on establishments that import. The proposed Regulations require that establishments that import donor sperm and ova ensure that the sperm or ova have been processed by a registered primary establishment. Given that primary establishments would need to register and to attest to having evidence demonstrating compliance with the Regulations to maintain registration, Health Canada would be provided with the regulatory tools needed to determine if the requirements of the Regulations are being met, and the Department would be allowed to work directly with the establishments to help ensure compliance. If the facility that processed the donor sperm or ova was not registered under the proposed Regulations, then the importing establishment would have to be registered as, and meet the requirements of, a primary establishment, including ensuring that the donor sperm or ova is processed in accordance with the Regulations.

1.1.2 Importing or distributing establishments

Due to the requirements placed on primary establishments and the relatively lower level of risk for importing and distributing activities, establishments would be required to notify the Minister prior to importing or distributing donor sperm or ova for use in AHR. An importing establishment would be required to ensure that the donor sperm or ova were processed by a registered primary establishment. The proposed Regulations would also require establishments that import or distribute donor sperm or ova for use in AHR to provide the Minister with an annual attestation that would include certifying they have evidence to demonstrate that they are in compliance with the Regulations.

1.2 Health professionals

As defined in the Regulations, a health professional, as a person who is authorized by the laws of their province or territory to make use of donor sperm or ova in AHR, would not be considered an establishment when they do not conduct activities other than the following: (i) making use of donor sperm or ova, or distributing donor sperm to a recipient for their personal use; (ii) preparing, quarantining, labelling or storing donor sperm or ova only for the purpose of making use of that sperm or ova; or (iii) preparing, quarantining, labelling or storing donor sperm only for the purpose of distributing sperm to a recipient for their personal use. As an integral part of the health and safety framework, health professionals would be required to meet certain regulatory requirements with regard to records to permit the traceability of the donor sperm or ova, related to errors, accidents, and adverse reactions and related to exceptional access and directed donations.

Where a person that is authorized to make use of donor sperm or ova conducts any activity other than those listed in the definition of a health professional, that person would be considered an establishment and would be subject to the relevant establishment requirements that correspond to the activities being carried out.

1.3 Donor suitability

The proposed Regulations provide two distinct schemes for assessing donor suitability: regular process and directed donation process.

1.3.1 Regular process for donor sperm and ova

The regular process would establish the standard requirements of assessing donor suitability, as it would apply to all anonymously donated sperm and ova.

The primary establishment would be responsible for ensuring that the donor suitability assessment is conducted. The proposed Regulations lay out the required steps for the donor suitability assessment, and the technical requirements for conducting them would be set out in a directive incorporated by reference into the Regulations. The technical requirements would include screening and testing sperm and ova donors to reduce the risk of infection and genetic disease transmission from the donor to the recipient or to the child born from the use of the donor's sperm or ova. The directive would also set out the exclusion criteria that would be used to establish whether a donor is suitable or not for the purpose of the regular process. Health Canada would have the ability to amend this directive from time to time, with amendments that are consistent with the purpose of reducing risks to human health and safety.

Establishments would be required to quarantine all donor sperm and ova that they process, which includes, among other things, segregating the sperm and ova and ensuring that they are not distributed. Establishments would be required to continue to keep sperm and ova in quarantine until the medical director of the primary establishment responsible for the donor sperm or ova quarantine has taken certain steps, including determining that the donor is suitable and that the donor sperm or ova can be released from quarantine.

These requirements would have to be met for all anonymous donor sperm and ova, with the exception of two exceptional circumstances: (1) previous exposure: for sperm, if the intended recipient has already been exposed to a donor's sperm that was retested at the same time as the sperm being requested; for ova, if the intended recipient has already been exposed to a donor's ova obtained on the same day as the ova requested; or (2) genetic sibling: if donor sperm or ova were used to create a child for an individual or couple and the requested sperm or ova from the same donor are to be used to create another child for the same individual or couple. Donor sperm and ova that do not meet all the requirements under the regular process, but that meet one of these circumstances, could still be considered for release from quarantine through exceptional access.

For the specific sperm or ova to be released from quarantine through exceptional access, certain requirements would need to be met. First, a health professional would need to initiate exceptional access on behalf of a recipient. The primary establishment would then be required to ensure the creation of a summary document that contains detailed information regarding that sperm or ova. The donor sperm or ova would have to be accompanied by a document that states that it is for exceptional access, and it would have to be segregated from other donor sperm and ova. Finally, prior to making use of the sperm or ova, a health professional would need to document that, based on their medical opinion, using the donor sperm or ova does not pose any serious human health and safety risks. A health professional would also be required to document that he or she has informed the recipient of the risk that the use of the donor sperm or ova could pose to human health and safety and that he or she has obtained the recipient's written consent.

1.3.2 Directed donation process for donor sperm and ova

The directed donation process would provide a means for the use of donor sperm or ova when the recipient and the donor know each other but are not each other's spouse, common-law partner, or sexual partner. While such donors could proceed through the regular process, the option to use the directed donation process instead would make it easier for Canadians who know their donor to proceed with building their families.

The directed donation process would also allow sperm or ova from a known donor to be imported, distributed and used, even if that donor does not meet all of the donor suitability requirements under the regular process, as any associated health risks could be individually assessed and mitigated in such circumstances.

The directed donation requirements would be largely similar to the regular process requirements, with certain differences. Specifically, a health professional would need to initiate the process for directed donation on behalf of a recipient. The assessment of the donor would not require that the donor be retested and a donor would not be automatically excluded if they meet certain screening or testing results. Instead, a primary establishment would have to ensure that information regarding the donor is reviewed by its medical director who uses it to create a summary document. Prior to making use of the donor sperm or ova, a health professional would be required to document that, based on their medical opinion, using the donor sperm or ova does not pose a serious risk to human health and safety. The health professional would also be required to document that he or she has informed the recipient of the risk that the use of the sperm or ova could pose to human health and safety, and that he or she obtained the recipient's written consent. The sperm and ova would also have to be accompanied by a document that states that it is for directed donation, and it would be segregated from other donor sperm and ova.

1.4 Identifying and labelling

The proposed Regulations include identification and labelling requirements that would support the safety and traceability of donor sperm and ova, and assist inspectors with compliance and enforcement activities.

Primary establishments would be required to ensure that a donor identification code is assigned to each donor, and that a donation code is assigned to each donation of sperm and ova. An establishment that labels would be responsible for ensuring that each container of donor sperm or ova is labelled with a donation code and a donor identification code to link it to its date of donation and donor. The proposed Regulations also provide the requirements for documentation that would be required to accompany each container of donor sperm or ova as the material goes through the distribution chain to help verify that it complies with the Regulations, including donor suitability assessment information and information needed for traceability.

1.5 Quality management

To reduce risks to the safety of donor sperm and ova as well as to human health and safety, all establishments, which would include primary establishments, would be required to meet quality management requirements in respect of the processing, importing and distributing activities that they conduct. Health professionals would be subject to limited quality management provisions regarding error, accident and adverse reaction investigation and reporting, as well as records.

1.5.1 Quality management system

Establishments would be required to establish and maintain a quality management system for the activities they conduct that is intended to prevent the contamination or cross-contamination of sperm or ova and the transmission of infectious disease. The requirements of a quality management system would include process controls, environmental and monitoring controls, and shipping standards, as well as systems for process validation, process improvement, internal auditing, training of personnel, tracing sperm and ova from the donor to the recipient, and records management. Each establishment would be required to conduct internal audits every two years of the activities it carries out to verify that those activities comply with the Regulations and its own standard operating procedures.

1.5.2 Standard operating procedures

Establishments would be required to have standard operating procedures for all components of their quality management systems and for all activities that they conduct. The procedures would be required to meet certain requirements, and establishments would have an obligation to review them every two years, following any regulatory amendments, and when a deficiency is revealed.

1.5.3 Personnel, facilities, equipment and supplies

Establishments would be required to have sufficient and qualified personnel, as well as suitable facilities, environmental control systems, equipment, and supplies. Establishments that distribute, import or make use of donor sperm or ova would also be required to examine both immediate and shipping containers for compliance with the Regulations. As well, the Regulations would set out that an establishment that ships donor sperm or ova would be required to use shipping containers that are capable of resisting damage, maintaining the safety of the sperm or ova, and maintaining adequate environmental conditions during the duration of the shipping.

1.5.4 Errors, accidents and adverse reactions

Requirements would be introduced so that donor sperm or ova that are the subject of an error or accident or that may be the cause of an adverse reaction could be quickly identified and quarantined.

Establishments and health professionals would be required to take certain actions in the event of an error, accident or adverse reaction, which would depend on the circumstances. They would include initial measures such as the quarantine of any donor sperm or ova implicated in an error, accident, or adverse reaction, and sending notices to other establishments or health professionals that may have any of the implicated donor sperm or ova. They could progress to, for instance, reporting to Health Canada, as well as implementing corrective measures to prevent further errors, accidents or adverse reactions.

There are also provisions that would permit donor sperm or ova implicated in an error, accident, or adverse reaction to be released from quarantine if it is requested for exceptional access, under the same circumstances and meeting the same requirements as the release for exceptional access under the regular process.

1.5.5 Records

The record requirements would support the traceability of donor sperm and ova, and assist the designated inspectors in verifying compliance with the Regulations. All establishments and health professionals would be required to maintain these records for a period of 10 years following their creation unless otherwise specified in the Regulations.

Establishments would be responsible for keeping records that contain all documents and information required in the Regulations, as well as all other records that demonstrate their compliance with the Regulations. Among other things, they would need to keep records on all donor sperm and ova that they processed, and on all establishments and health professionals to which they distributed donor sperm and ova.

Establishments and health professionals that conduct an investigation into an error, accident or adverse reaction, or that have received a notice of an investigation, would be required to maintain records of the investigation as well as any action taken.

Establishments and health professionals would also be required to maintain records on all donor sperm or ova that they use, including, among other things, information about the establishment from which they received the donor sperm or ova and the recipient who has undergone an AHR procedure in which the sperm or ova was used. Health professionals who distribute sperm to a recipient for their personal use would also be required to keep specific records.

1.6 Donor sperm and ova obtained prior to the coming into force of the Regulations

Under transitional provisions, the proposed Regulations would permit the import, distribution and use of donor sperm processed in compliance with the Semen Regulations that was obtained prior to the coming into force of the proposed Regulations, as well as donor sperm authorized under the Donor Semen Special Access Programme. Certain labelling and documentation requirements of the Regulations would have to be met in that specific situation.

Donor sperm or ova obtained prior to the coming into force of the proposed Regulations could otherwise be imported, distributed or used if they could be brought into compliance with the proposed requirements, such as for the directed donation process or exceptional access.

2. Reimbursement Related to Assisted Human Reproduction Regulations

The AHRA permits, in accordance with the regulations, the reimbursement of certain expenditures incurred by a donor in the process of donating sperm or ova, by any person for the maintenance or transport of an IVE, and by a surrogate mother in relation to her surrogacy. The Act also permits a surrogate mother to be reimbursed for loss of work-related income incurred during her pregnancy if a qualified medical practitioner certifies in writing that continuing to work may pose a risk to her health or that of the embryo or foetus.

The proposed Regulations would establish broad categories of expenditures that could be incurred by a donor or surrogate and that could subsequently be reimbursed. For example, donors and surrogate mothers could incur expenditures as a result of travel or seeking legal or counselling services in the course of their donation or surrogacy. Surrogate mothers could also incur expenditures related to maternity clothing, prenatal care or the delivery of the child. Where a surrogate mother has a loss of work-related income incurred during her pregnancy, the proposed Regulations provide detail about the documentation that would be needed for reimbursement. In addition, a person could be reimbursed for expenditures incurred in the maintenance or transport of an IVE, which could include, for example, the storage of an IVE. The proposal also sets out documentation and record-keeping requirements for each reimbursement, and would give the Minister of Health the ability to request records or any additional information from persons who maintain a record in relation to a reimbursement.

3. Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act

Most of the administration and enforcement provisions in the AHRA that are not in force (sections 45 to 58) do not require regulations to come into force, including sections that authorize the Minister to designate inspectors and sections that set out the powers of inspectors. Two provisions do require regulations to come into force, and regulations are also proposed to add detail related to a third provision.

3.1 Designated officer

The AHRA requires that the notion of "designated officer" be defined in the regulations. The designated officer is responsible, among other things, for providing directions regarding the handling of certain seized or forfeited material or information. Health Canada proposes to define the "designated officer" as the Director General responsible within the Department for overseeing compliance and enforcement activities of the AHRA. Health Canada has determined that an individual at that level is appropriate given the sensitive nature of some of the material that could be seized or forfeited. It considers that the proposed definition is general enough to accommodate any future departmental reorganization while being specific enough to allow the designated officer to be identified by referring to an organizational chart.

3.2 Treatment of seized or forfeited material and information

Among the different inspection powers set out in the AHRA, inspectors designated under the Act would have the ability to seize any material and information by means of which or in relation to which they believe, on reasonable grounds, that the AHRA has been contravened. Seizure could be considered, for instance, in the case of certain specific activities prohibited under the AHRA, or if significant issues with the safety of donor sperm or ova occurred. Seized material or information could be restored to the person from whom it was seized following an application to a provincial court judge. If such application is not made within 60 days after the date of seizure, or if such an application does not result in an order of restoration, then the seized material or information is forfeited to Her Majesty.

If inspectors seize any viable donor sperm, ova or IVEs, the AHRA requires the designated officer to make reasonable efforts to preserve them. The Act also requires that any further measures with respect to seized sperm, ova or IVEs be consistent with the consent of the donor, or, if consent cannot be obtained, that they be in accordance with the regulations. The proposed Regulations would set out who the donor is and whose consent would have to be obtained in the case of an IVE; specifically, it would specify when an individual or when a couple is considered the donor of an IVE for the purpose of further measures. Health Canada may be unable to locate or determine the identity of the donor of seized sperm, ova or IVEs because, for instance, they donated anonymously and laws prevent the disclosure of the donor's identity. If donor sperm, ova or IVEs are seized and then forfeited to Health Canada, and if it is impossible to obtain the consent of the donor for further measures, the proposed Regulations would only permit the designated officer to direct the disposal of the forfeited donor sperm, ova or IVEs following 60 days after it had been forfeited.

3.3 Notice seeking restoration of seized material or information

The AHRA sets out the process for a person to apply for an order of restoration of seized material or information, including the requirement that a notice be sent to the Minister. The proposed Regulations add details to this process by setting out the notice requirements that a person from whom material or information is seized would need to follow if they intend to make an application for an order of restoration.

4. Regulations Amending the Assisted Human Reproduction (Section 8 Consent) Regulations

The proposed amendments to the Consent Regulations make minor modifications to improve the scheme. One amendment would help preserve the anonymity of donors that donated on the condition of anonymity, where the person making use of the donated sperm, ova or IVEs is not the person who originally obtained the consent directly from the donor. Currently, the Regulations state that the person who makes use of sperm, ova or IVEs must have the written consent of the donor prior to their use. The amendments would set out that, in cases of anonymous donations, the consent requirements would be met if the person making use of the donor sperm or ova has, prior to making use, a document from the person who originally obtained consent from the donor, attesting, among other things, that written consent was obtained in accordance with the prescribed requirements and specifying the purpose(s) for which the donated sperm, ova or IVEs can be used. For example, a sperm bank would obtain written consent from an anonymous donor, and then provide to a fertility clinic a separate document that attests, among other things, that the sperm bank received the donor's written consent.

The proposed Regulations would also add a new record retention provision that requires that persons who obtain or make use of sperm, ova or IVEs are responsible for keeping copies of all the documents they are required to have under the Consent Regulations for a period of 10 years after the date on which the sperm, ova, or IVEs are used, or sperm or ova are removed from the donor's body.

In addition, certain provisions of the Consent Regulations would be amended in order to clarify a number of terms and phrases and improve consistency between the French and English versions. The title would also be changed to Consent for Use of Human Reproductive Material and In Vitro Embryos Regulations, to bring it in line with the titles proposed for the other draft regulations.

5. Repeal of the Processing and Distribution of Semen for Assisted Conception Regulations and consequential amendment to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

The proposed Safety of Sperm and Ova Regulations would replace the Semen Regulations for donor sperm. As a result, the Semen Regulations would be repealed, concurrent with the coming into force of the proposed Regulations. The Donor Semen Special Access Programme (DSSAP), which is part of the Semen Regulations, would also end at that time. Access to the types of donor semen that are currently obtained through the DSSAP would be possible through the proposed directed donation process and exceptional access provisions.

A consequential amendment to subsection 3(1) of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations would be made to repeal the paragraph dealing with semen regulated under the Semen Regulations in the non-application section of those Regulations. Semen and ova that are regulated under the AHRA would continue to not be subject to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations pursuant to the non-application provision that is currently in those Regulations.

6. Coming into force and transitional provisions

The proposed new and amended regulations include coming-into-force dates. It is Health Canada's intent that the coming-into-force dates of the new regulations would be the same as the coming into force of the sections of the AHRA that they support. The regulations also propose transitional provisions in the Safety of Sperm and Ova Regulations and the Consent Regulations.

6.1 Safety of Sperm and Ova Regulations

The proposed Safety of Sperm and Ova Regulations (section 10) would come into force six months after the publication of the Regulations in the Canada Gazette, Part II, with a few exceptions for certain provisions. This period is proposed to provide industry with the time needed to update their practices to come into compliance with the Regulations. It is proposed that those provisions that relate to listing or including registration numbers in documentation, as well as section 3, come into force 12 months after publication, to provide time to primary establishments to get and communicate their registration numbers.

Transitional provisions would allow primary establishments that process donor sperm or ova before the day in which these Regulations come into force to continue to process donor sperm or ova without a registration from Health Canada, provided they have filed a registration application within 90 days after the coming into force of the Regulations. This would apply until the registration number is issued or the application for registration is refused. Similarly, transitional provisions would allow establishments that distribute or import donor sperm or ova before the day on which these Regulations come into force to continue conducting those activities without prior notification, provided that they notify Health Canada within 90 days after the coming into force of the Regulations.

The Semen Regulations would be repealed six months after publication in the Canada Gazette, Part II, to coincide with the coming into force of the proposed Safety of Sperm and Ova Regulations. At the same time, the Safety of Human Cells, Tissues and Organs for Transplantation Regulations would be amended to remove from the non-application provisions of those Regulations the paragraph dealing with semen regulated under the Semen Regulations. Section 4.2 of the AHRA, which states that the Food and Drugs Act does not apply in respect of sperm and ova to be used for the purpose of AHR, would also be brought into force six months after publication.

6.2 Reimbursement Related to Assisted Human Reproduction Regulations

The proposed Reimbursement Related to Assisted Human Reproduction Regulations (section 12) would come into force immediately upon publication in the Canada Gazette, Part II. This is proposed to provide stakeholders with the needed clarity on which expenditures can be reimbursed.

6.3 Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act

The proposed Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act to support subsections 51(1) and 52(3) and section 54 of the AHRA would come into force upon publication in the Canada Gazette, Part II, which would coincide with the coming into force of sections 45 to 58 of the AHRA.

6.4 Regulations Amending the Assisted Human Reproduction (Section 8 Consent) Regulations

The amendments to the Consent Regulations would come into force six months after the publication of the proposed Regulations in the Canada Gazette, Part II. Transitional provisions are also proposed in the case of anonymous donations of sperm or ova obtained, or IVE created prior to December 1, 2007, the day on which the Consent Regulations came into force. Consistent with the scenarios provided for in the existing transitional provisions found in section 16 of the Consent Regulations, in cases of anonymous donations, instead of having the written consent of the donor prior to use, the person who makes use of sperm, ova or IVE needs to only have a document signed by the person who originally obtained the written consent of the donor, attesting that the donor has provided written consent dated prior to December 1, 2007, for the use of the sperm, ova, or IVE for the purpose intended.

Regulatory and non-regulatory options considered

Option 1: Do not introduce regulations under the AHRA and leave existing regulations in place (maintain the status quo)

The status quo is not considered to be a viable option, as it would not address the gaps in the oversight of safety of donor sperm and ova. The safety of donor sperm would remain regulated by out-of-date requirements under the Semen Regulations that are insufficiently aligned with those in other jurisdictions. Donor ova would be subject to no federal safety oversight, with Canadians remaining at risk of exposure to infectious diseases through their use. There would be no regulations to clarify the expenditures that may be reimbursed for certain parties involved in AHR, leaving those parties in confusion on what is permitted. The Consent Regulations would continue to include a number of gaps, including provisions that could result in the unintentional compromise of the anonymity of donors.

Furthermore, not bringing into force the reimbursement and administration and enforcement provisions of the AHRA that were enacted in 2004, due to a lack of supporting regulations, would lead to the automatic repeal of those provisions, as per the Statutes Repeal Act, unless a request for deferral from repeal is granted every year.

In addition, this option would fail to fulfill the intent of Parliament as expressed in the Act.

Option 2: Develop the regulations necessary to bring into force the reimbursement and administration and enforcement sections of the AHRA, and regulate donor sperm and ova under the Food and Drugs Act

Health Canada considered the feasibility of maintaining the safety requirements for donor sperm in their current location under the Food and Drugs Act and adding safety requirements there for donor ova. This would continue to use the authorities of the Food and Drugs Act while permitting modernization of the requirements.

This is not, however, considered an adequate option, as it would fail to fulfill the intent of Parliament as expressed in section 10 of the AHRA. The purpose of section 10 of the AHRA is to reduce the risks to human health and safety from donor sperm and ova used for the purpose of assisted human reproduction.

Option 3: Propose a new set of regulations under the AHRA (recommended approach)

This approach is preferred as it provides for a cohesive, consistent regulatory framework that oversees the safety of donor sperm and ova, reimbursement, and consent, with administration and enforcement authorities. Furthermore, this option would fulfill parliamentary intent.

Benefits and costs

Scope and baseline scenario

The cost-benefit analysis (CBA) seeks to explain the qualitative and quantitative costs and benefits of the proposed regulations. All calculated costs and benefits have been calculated over a 10-year period, and the present value figures have been discounted by 7% as required by the Treasury Board Secretariat. ^{footnote 14} A conservative approach to the costs and benefits has been taken whereby Health Canada is of the view that the benefits in this analysis are understated and the costs are overstated. This approach was taken due to the limited data available on the AHR industry as well as the use of AHR in Canada. The data used in this CBA were collected through costing surveys distributed to the Canadian AHR industry and stakeholders, drawn from published literature, or based on Health Canada's operational experience. Despite these multiple sources of information, there were several data gaps on the state of AHR in Canada, which stakeholders have also identified. The CBA, in some instances, provides and explains estimates for figures that lack robust data, while in other instances, it acknowledges the lack of data. The full cost-benefit analysis is available upon request.

The focus of this CBA is the costs and benefits associated with the proposed Safety of Sperm and Ova Regulations, as only these proposed Regulations have significant cost implications to industry and government. This proposal would impose costs on Canada's AHR industry, principally on its members that would meet the definition of an establishment. Establishments are anticipated to consist of sperm and ova banks and other donor sperm and ova processors that would be considered primary establishments; importers and distributors of donor sperm or ova; facilities that perform processing for donor sperm or ova; and health care providers that meet the definition of establishment. They are located across Canada, most commonly in cities. Health Canada estimates that there are approximately 105 establishments that would be subject to the proposed Safety of Sperm and Ova Regulations. This number has been estimated based on the current number of regulated parties under the Semen Regulations. Based on the best available historical industry data, Health Canada has opted against assuming growth in the number of establishments in Canada's AHR industry in the CBA. According to Health Canada's inspection database, the number of regulated parties under the Semen Regulations has ranged between 102 and 105, from 2011 to 2016, with no identified trend. This low variability in regulated parties suggests a lack of growth in AHR facilities involved in donor sperm, and due to the low amount of activity in ova donations in Canada, it is assumed to be similarly flat. Without any data showing industry growth, Health Canada assumes that the number of establishments is likely to remain steady, and that existing establishments would meet any growth rate by increasing their capacity by adding staff and space. In addition, no data is available on the current operating costs of members of the AHR industry.

Given the lack of precise figures on the quantity of donor sperm and ova used in Canada, a study and an industry report were used to estimate these metrics. The potential number of recipients of donor sperm was used to estimate the quantity of donor sperm used annually. A 2017 study using demographic data broadly estimated that 7 866 persons in Canada may seek donor sperm for their reproductive needs at any one time. ^{footnote 15} An annual report prepared by the Canadian Fertility and Andrology Society in 2012 found that, on an annual basis, approximately 617 donor ova were used in Canada. ^{footnote 16} Using these values, Health Canada estimates that roughly 9 000 Canadians seek donor sperm or ova to meet their reproductive needs each year.

Similarly, an estimated growth rate was used to calculate costs that are dependent on the number of donor sperm or ova used annually in AHR. The number of AHR procedures in Europe, Australia and the United States has seen growth rates of 5% to 10% annually in recent years. ^{footnote 17} Assuming a similar growth rate in Canada, Health Canada estimated an increase in demand for AHR at the high end of that range, at 10% annually.

Given the existing Semen Regulations, and based on Health Canada's knowledge of the AHR industry, establishments are believed to already be meeting several of the proposed requirements. The Semen Regulations include requirements for donor suitability assessments for donor sperm, including screening and testing, and establishments are believed to already be performing the incremental requirements proposed in these Regulations. Health Canada also believes that establishments currently operating already meet the minimum requirements for facilities, equipment, supplies, and appropriate environmental monitoring.

Overview

It is projected that the incremental cost to these establishments to meet the proposed requirements would be $3,685,449 over a 10-year period. Health Canada anticipates that its compliance and enforcement program costs would be $6,677,430 over a 10-year period. The total costs for the proposal would translate to a present value (PV) cost (discounted by 7%) of $10,362,879 over a 10-year period.

There are quantitative and qualitative benefits associated with the proposed Safety of Sperm and Ova Regulations. The quantitative benefits include the anticipated cost savings to Health Canada associated with ending the Donor Semen Special Access Programme (DSSAP), representing a present value cost (discounted by 7%) of $103,949 over a 10-year period.

The qualitative benefits of the proposed Safety of Sperm and Ova Regulations are significant. These include an increased ability to avoid infectious or genetic disease transmission from donor sperm or ova to the recipient or donor-conceived offspring, as well as greater confidence in the safety of donor sperm and ova in Canada. Benefits also include an increased ability to identify, trace and remove donor sperm or ova that are the subject of an error or accident from the supply chain, as well as increased accountability of regulated parties.

The qualitative benefits of the proposed Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act as well as the bringing into force of the administration and enforcement sections of the AHRA include an improved ability to help those affected by the use of AHR technologies, especially women using these technologies and children born as a result of the use of these technologies.

The qualitative benefits of the proposed Reimbursement Related to Assisted Human Reproduction Regulations, which permit the reimbursement of certain expenditures to sperm and ova donors, surrogate mothers, and persons involved in maintaining and transporting IVEs, include providing clarity to those offering and receiving such reimbursements so that they can undertake these transactions without concerns that they could be contravening the Act.

Table 1: Cost-benefit analysis (all values in 2017 dollars)

Quantified impacts ($)

	Stakeholders	Base Year	Final Year	Average	Total (PV)
Benefits
Ending DSSAP	Health Canada	$14,800	$14,800	$14,800	$103,949
Total savings		$14,800	$14,800	$14,800	$103,949
Costs
Administrative costs	Establishments	$77,369	$81,361	$79,114	$553,971
Regulatory compliance costs	Establishments	$1,266,243	$370,495	$418,202	$3,131,478
Compliance and enforcement	Health Canada	$745,007	$745,007	$745,007	$5,232,616
Administrative enforcement	Health Canada	$205,709	$205,709	$205,709	$1,444,814
Total costs		$2,294,327	$1,402,572	$1,448,032	$10,362,879
Net benefits		−$2,279,527	−$1,387,772	−$1,433,232	−$10,258,930
Qualitative impacts Benefits Strengthened donor suitability assessment requirements regarding donor sperm, including donor screening and testing, to prevent disease transmission to recipients of donor sperm or to children created from donor sperm. First-time establishment of federal regulations for the safety of donor ova to prevent disease transmission to recipients of donor ova or to children created from donor ova. Increased regulatory oversight and compliance and enforcement activities to support the removal of non-compliant donor sperm and ova from the supply chain. Greater confidence in the safety of donor sperm and ova from an increased ability to identify, trace and remove donor sperm or ova that are the subject of an error or accident, or the source of an adverse reaction, from the supply chain. Increased opportunities to mitigate the risk of transmitting genetic diseases to donor-conceived offspring through more information about a sperm or ova donor's known family history of genetic disease. Increased accessibility to donor sperm or ova from a known donor by formalizing directed donation requirements in regulations. Elimination of wait time associated with Health Canada's reviews and authorizations of the special access application to use, import or distribute donor sperm under the existing Donor Semen Special Access Programme. Increased clarity to those offering and receiving reimbursements, as permitted under the AHRA, allowing them to undertake these transactions without concerns that they could be contravening the Act. Improved ability by Health Canada to administer and enforce the AHRA to help protect those affected by the use of AHR technologies, especially women using these technologies and children born as a result of the use of these technologies.

Costs

All estimated costs are calculated based on the requirements of the proposed Safety of Sperm and Ova Regulations, as Health Canada believes that the costs of the Reimbursement Related to Assisted Human Reproduction Regulations, the Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act, and the amendments to the Consent Regulations would be negligible.

Table 2 provides the forecasted total cost for the estimated 105 establishments in Canada that would be directly impacted by the proposed Safety of Sperm and Ova Regulations. All costs in the table and in the text are the total estimated costs for all establishments.

Table 2: Total costs to establishments (all values in 2017 dollars)

Quantified Impacts	Year 1	Year 2	Year 3	Year 4	Year 5	Year 6	Year 7	Year 8	Year 9	Year 10	Average	Total (PV)
1. Registration/ Notification	$11,878	$0	$0	$0	$0	$0	$0	$0	$0	$0	$1,188	$11,101
2. Annual statement	$10,868	$10,868	$10,868	$10,868	$10,868	$10,868	$10,868	$10,868	$10,868	$10,868	$10,868	$76,329
3. Amend or change data note *	$3,570	$3,570	$3,570	$3,570	$3,570	$3,570	$3,570	$3,570	$3,570	$3,570	$3,570	$25,074
4. Additional labelling	$58,500	$64,350	$70,785	$77,864	$85,650	$94,215	$103,636	$114,000	$125,400	$137,940	$93,234	$621,128
5. Record keeping note *	$2,940	$3,234	$3,557	$3,913	$4,304	$4,735	$5,208	$5,729	$6,302	$6,932	$4,686	$31,216
6. Information request note *	$23,126	$23,126	$23,126	$23,126	$23,126	$23,126	$23,126	$23,126	$23,126	$23,126	$23,126	$162,429
7. Record retrieval note *	$40,425	$40,425	$40,425	$40,425	$40,425	$40,425	$40,425	$40,425	$40,425	$40,425	$40,425	$283,928
8. Develop quality management system/SOPs	$288,750	$0	$0	$0	$0	$0	$0	$0	$0	$0	$28,875	$269,860
9. Update and review SOPs	$70,809	$0	$141,619	$0	$141,619	$0	$141,619	$0	$141,619	$0	$63,728	$447,977
10. Self-audit	$154,383	$154,383	$0	$154,383	$0	$154,383	$0	$154,383	$0	$154,383	$92,630	$668,109
11. Employee training	$603,750	$0	$0	$0	$0	$0	$0	$0	$0	$0	$60,375	$564,252
12. Investigation — General	$32,517	$32,517	$32,517	$32,517	$32,517	$32,517	$32,517	$32,517	$32,517	$32,517	$32,517	$228,387
13. Investigation — Quarantine	$24,281	$24,281	$24,281	$24,281	$24,281	$24,281	$24,281	$24,281	$24,281	$24,281	$24,281	$170,541
14. Investigation — Communication	$10,507	$10,507	$10,507	$10,507	$10,507	$10,507	$10,507	$10,507	$10,507	$10,507	$10,507	$73,794
15. Investigation — Reporting note *	$7,307	$7,307	$7,307	$7,307	$7,307	$7,307	$7,307	$7,307	$7,307	$7,307	$7,307	$51,324
Total	$1,343,611	$374,568	$368,562	$388,761	$384,174	$405,934	$403,065	$426,713	$425,922	$451,856	$497,317	$3,685,449

Industry costs

The estimated costs are calculated either using the average cost per establishment multiplied by the number of establishments, or using the average cost per unit of donor sperm or ova multiplied by the number of units. The average cost per establishment or per unit is the average of the cost estimates provided by stakeholders in response to the costing survey. Some costs required further assumptions such as the percentage of establishments to which the cost is applicable, or the frequency of the incurred cost. These assumptions are described with each cost below.

Nos. 1–3. The first three costs in Table 2 are for requirements of certain establishments to inform Health Canada that they are participating in Canada's AHR industry. Primary establishments would have to register with Health Canada by submitting an application for registration, while establishments that import or distribute donor sperm or ova would need to notify the Minister of Health prior to undertaking the activity of import or distribution. In the absence of data regarding how many establishments would need to register versus notify, Health Canada has estimated the one-time registration and notification cost at $113 per establishment based on the wage hours required for the establishments to conduct their registration or notification process. The total overall cost would be $11,878 for all 105 establishments in the first year the Regulations are in force.

The proposed Regulations would also require primary establishments and establishments that import or distribute donor sperm or ova to provide the Minister with an annual statement certifying that they have sufficient evidence to demonstrate that they comply with the Regulations. The annual cost of these activities is estimated to be $10,868. Establishments would be required to notify Health Canada any time they update information in their registrations or notifications. It is assumed that in a given year, 25% of establishments would change data, so the cost was calculated as the average cost per establishment multiplied by the number of establishments (105), multiplied by 25%. The annual cost of data changes is estimated at $3,570.

No. 4. Establishments that label units would be required to label each unit of donor sperm and ova, and provide accompanying documentation. The cost is calculated as the average cost for labelling and documentation per unit multiplied by the number of units of donor sperm and ova (9 000 in the first year). The number of units is projected to increase by 10% each year. The estimated incremental cost associated with the proposed labelling requirements is $58,500 in the first year, and the cost increases by 10% annually as per the estimated growth rate. As a result, the average incremental cost for labelling is estimated to be $93,234 annually in the 10-year period.

Nos. 5–7. Under the proposed Regulations, establishments and health professionals would be responsible for the record keeping of specific documentation, including on the donor sperm and ova they process or receive, and any investigations they undertake that are required by the proposed Regulations. Record-keeping requirements throughout the distribution chain are necessary to permit the traceability of donor sperm and ova as well as to demonstrate compliance with the Regulations. The cost is calculated as the average cost of record keeping for each unit multiplied by the number of units of donor sperm and ova. Based on figures provided through survey responses, it is estimated that the total industry cost to maintain records electronically and physically would be $2,940 in the first year. This cost is expected to increase by 10% annually as it takes into account the number of sperm or ova used.

The proposed Regulations would permit the Minister to ask for any relevant information in support of a primary establishment's application for registration or to demonstrate that the activities that it conducts, or is responsible for, are being carried out in compliance with the Regulations. Health Canada could also ask any establishment to provide it with any relevant information to demonstrate that its ongoing activities are being conducted in compliance with the Regulations. Based on current data, it is assumed that the Minister may make up to three requests per establishment per year for information. The cost is calculated as the average cost per establishment multiplied by the number of establishments, multiplied by three, for an average annual cost to industry estimated at $23,126.

On the assumption that establishments would need to retrieve physical records to respond to each of the three information requests from the Minister, it is estimated that there would be an additional annual cost of $40,425 for record retrieval.

Nos. 8–11. The proposed Regulations would require establishments to have in place a quality management system (QMS) and standard operating procedures (SOP). It is estimated that half of all establishments have a QMS and SOPs in place. Therefore, Health Canada estimates that half of establishments would incur a one-time expenditure to develop and implement a QMS and SOPs to comply with the proposed Regulations, at a total cost of $288,750. The cost is calculated as the average cost per establishment multiplied by the number of establishments, multiplied by 50%.

The proposed Regulations would require establishments to review their SOPs every two years, following an amendment to the Regulations, or when a deficiency is revealed through an investigation or audit. The estimated average annual cost for establishments to review their SOPs every two years is $63,728. In the first year, the cost is calculated as the average cost per establishment multiplied by the number of establishments, multiplied by 50%, as it is assumed that the half of establishments with existing SOPs would review and update them in order to comply with the new Regulations. Subsequently, in every other year (years three, five, seven, and nine) the cost is calculated as the average cost per establishment multiplied by the number of establishments.

The proposed Regulations would also place a requirement on establishments to perform an audit every two years of their activities. The estimated annual cost for all establishments to perform a self-audit is $154,383, and the estimated average cost for establishments to self-audit the first year and then every two years is $92,630. Regarding the timing of the reviews and self-audits, it is assumed it would be standard industry practice to perform a self-audit in the first year that the proposed Regulations are in force, and then begin biennial self-audits beginning in year two. It is also assumed that establishments would subsequently alternate the biennial audits with the SOP reviews and updates to distribute these costs more evenly.

Under the proposed Regulations, establishments would also be required to have qualified personnel and a system in place to provide personnel with initial and ongoing training. It is estimated that this requirement would impose a one-time compliance cost of $603,750 on establishments in the first year, to train staff in accordance with the proposed Regulations. Health Canada assumes that the cost associated with the ongoing training of personnel would be attributed to the establishment's own operational cost of doing business.

Nos. 12–15. The final four costs in Table 2 are for activities that establishments and, in some instances, health professionals would be required to undertake in the event of an error, accident, or adverse reaction. Health Canada has identified four incremental costs related to investigation and reporting requirements, and for each has assumed that 25% of establishments would participate in an investigation into an error, accident or adverse reaction on an annual basis. These four costs were calculated as the average cost per establishment multiplied by the number of establishments, multiplied by 25%.

In the event of a suspected error, accident or adverse reaction related to their activities, establishments and, in some instances, health professionals would be required to investigate. The average annual cost associated with 25% of establishments performing an investigation is $32,517. Under the proposed Regulations, establishments and health professionals may also be required to quarantine donor sperm or ova implicated in an error, accident or adverse reaction. The average annual cost to quarantine implicated donor sperm or ova would be $24,281.

In the event of an error, accident or adverse reaction, the proposed Regulations require communication among the establishments and health professionals that processed or received donor sperm or ova implicated in an error, accident or adverse reaction. Health Canada estimates the average annual cost for this communication at $10,507. Finally, for specific cases of errors, accidents or adverse reactions, establishments and, in some instances, health professionals would be required to provide reports to the Minister on, among other things, the event that triggered the investigation and the progress of the investigation. The average annual cost associated with 25% of establishments reporting to the Minister is estimated at $7,307.

Sensitivity analysis

Through the costing survey administered by Health Canada, AHR organizations were asked to provide Health Canada with all of the costs associated with the proposed Regulations. Survey participants were asked to provide cost estimates based on the actions they would need to take to meet the proposed regulatory requirements. To produce the most accurate estimate for the CBA, the data collected was analyzed and synthesized into a lower cost scenario (alternative scenario) and a higher cost scenario (current scenario) to formulate an industry average cost for each activity.

Table 3: Impact scenarios — Costs for AHR establishments and health professionals (in 2017 dollars)

Scenario Analyzed	Estimated Number of Establishments	Estimated Number of Health Professionals	Year 1	Year 10	Average	Total (PV)
Alternative scenario	49	56	$668,380	$254,357	$274,373	$2,016,016
Current scenario	105	0	$1,343,611	$451,856	$497,317	$3,685,449

Of the 105 establishments estimated for costing purposes, as informed by Health Canada's inspection database for the Semen Regulations over 2012–2017, six are Canadian processors and importers of donor semen that have notified Health Canada of their activities. These six processors and importers would be expected to be establishments under the proposed Regulations. The remaining 99 of the 105 represent health care providers (e.g. fertility clinics, doctors) who are expected, based on Health Canada's understanding of their activities, to be health professionals as defined in the proposed Regulations, and potentially establishments. Health Canada does not have data on donor ova processing, importation or facility use in Canada, so it assumes for the purposes of the cost-benefit analysis that they are included in this estimate.

Although Health Canada has applied all estimated costs that arise from the proposed Regulations to 105 establishments, Health Canada is aware that not all health care providers currently regulated under the Semen Regulations would be likely to assume all costs associated with the regulatory requirements. This is because an organization would need to comply with the proposed requirements particular to the activities they conduct, as an establishment or as a health professional.

In Table 3, costs for the higher cost, current scenario and a lower cost, alternative scenario are provided. The alternative scenario estimates 49 establishments, which consists of the 6 known establishments as well as 43 health care providers that are also assumed to be conducting activities that can only be performed by establishments, thereby assuming the full cost burden associated with these activities. The remaining 56 health care providers are assumed to meet the definition of health professionals. The alternative scenario is lower cost as health professionals would only assume costs related to the limited requirements that are proposed for them associated with record keeping and investigation; these costs are included in Table 2 as No. 5 and Nos. 12–15. The estimated industry cost for the alternative scenario is a lower $2,016,016 (PV) over a 10-year period, compared to the CBA's current scenario estimate of $3,685,449 (PV).

For the purposes of the cost-benefit analysis, Health Canada has chosen to apply the conservative, higher impact scenario to all costing figures, thereby assuming that all 105 AHR persons would meet the proposed definition of an establishment and be subject to the costs of all activities associated with establishments. This approach was selected to account for the possibility that each health care provider is conducting activities that can only be performed by establishments that under the proposed Regulations would result in them assuming costs related to establishment requirements.

The higher cost scenario also provides the most suitable estimate of the potential costs for industry to comply with the proposed Regulations given the lack of available data on the AHR industry, including the number of establishments that process, import or distribute only donor ova in Canada; the number of establishments, other than primary, importing or distributing, that may assume costs to meet the proposed requirements; and the potential impact on the fees for imported donor sperm and ova.

Government costs

Table 4: Health Canada costs for administering and enforcing the AHRA

Health Canada	Year 1	Year 2 to Year 10	Average	Total (PV)
Compliance and enforcement	$745,007	$745,007	$745,007	$5,232,616
Administrative enforcement	$205,709	$205,709	$205,709	$1,444,814
Total	$950,716	$950,716	$950,716	$6,677,430

The administration and enforcement provisions in the AHRA set out a framework through which designated inspectors would verify that parties comply with the Act.

Health Canada estimates the annual cost of implementing a compliance and enforcement program to oversee the new AHR regulatory framework at $950,716. The annual administration and enforcement cost of $745,007 would include four inspectors, one regulatory compliance and enforcement advisor and a registration officer. An additional annual expenditure of $205,709 would include the cost associated with inspections as well as information management and information technology development.

Other costs considered

As it is believed that most donor sperm and ova used in Canada are imported from the United States, it is likely that any increased costs assumed by U.S. and other foreign primary establishments that choose to register with Health Canada would be included in the fees associated with obtaining donor sperm and ova. While the proposed Regulations have been designed to match U.S. and Canadian industry practice to the extent possible, there would nonetheless likely be incremental costs. Due to a lack of data at this time, the cost analysis does not estimate a potential increase in fees charged to Canadian establishments or consumers. The recognition of these circumstances, however, contributed to the decision to use a conservative, higher impact estimate for overall costs, in an effort to better capture the impact of the proposed Regulations.

The proposed Reimbursement Related to Assisted Human Reproduction Regulations would only apply where, following a request for reimbursement, a person chooses to reimburse a sperm or ova donor or surrogate mother for expenditures assumed in relation to their donation or surrogacy or to any person for the maintenance or transport of an IVE as per the proposed categories of allowable expenditures. There would be no regulatory requirement for reimbursement to occur but, should individuals voluntarily opt to do so, the reimbursement would have to be in compliance with the Regulations. The principal information requirements in the proposed Regulations include the following items:

1. Sperm and ova donors, surrogates, and persons that maintain or transport an IVE would be required to collect receipts and prepare a declaration, including a list of expenditures;
2. Sperm and ova donors, surrogates, and persons that maintain or transport an IVE would be required to provide these documents to the person providing the reimbursement;
3. The person providing the reimbursement would be required to affirm and sign the declaration;
4. The person providing the reimbursement would be required to keep these records for six years; and
5. The person providing the reimbursement could receive a records request from the Department and be required to send specified records for verification.

Health Canada believes that the time required for sperm and ova donors, surrogates and persons that maintain or transport IVEs to complete item 1 in the list above, the preparation of a declaration, would be negligible. This is because the proposed declaration requirements were purposely kept light in recognition that Health Canada assumes that it would primarily be private citizens preparing the declaration for reimbursement. Further, Health Canada has no way of knowing how many people would choose to opt into reimbursement activities. Data about existing reimbursement activities is unavailable because, in the absence of regulations, any reimbursements that are happening now are not subject to Health Canada compliance and enforcement activities. Given that Health Canada has no way of estimating how many reimbursements would take place, the costs associated with item 1 could not accurately be described in the CBA. Only an estimated cost for item 5 in the list above has been calculated, as it is required as part of the administrative costs under the "One-for-One" Rule: three annual record requests would cost industry/private citizens an estimated $217 (PV) over 10 years.

While most of the costs for requirements in the proposal are attributable to the Safety of Sperm and Ova Regulations, the AHRA has provisions that specifically deal with the seizure and storage of information and material, including those that give designated inspectors the ability to seize and store information and material. The proposed Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act are required to operationalize three of the administration and enforcement provisions in the AHRA, which would thereby permit all administration and enforcement provisions of the Act to be brought into force. These proposed Regulations include details on the notice requirements should a person apply for the restoration of seized material or information. The incremental costs associated with the notification requirements are attributable to the Regulations. However, they have not been estimated because Health Canada believes that the time required for a person to complete such a notice would be negligible. This is because the notice requirements were purposely limited to only those basic elements that would typically be found in this type of notice and are not onerous. Further, Health Canada has no way of forecasting how often information or material would be seized nor any way of knowing how many people would apply for restoration of seized material or information by following the notice requirements. Given that the costs would be negligible, and given that Health Canada has no way of estimating a multiplier, the costs associated with the notice requirements could not accurately be described in the CBA.

The government costs for the administration and enforcement provisions related to seized material in the regulations have not been estimated separately. They are part of the full cost provided for Health Canada's compliance and enforcement program. The cost includes salary and other operating expenditures for all activities that would be required to enforce the Act and the proposed regulations, including seizures and storage.

The proposed amendments to the Consent Regulations include new provisions dealing with consent for the purposes of section 8 of the AHRA in cases where donations were made on the condition of anonymity as well as record-keeping requirements. As it is believed that these activities are already in practice by the AHR industry, the incremental costs are considered negligible.

Cost summary

The projected total cost to all establishments would be $3,685,449 over a 10-year period; this number includes costs for all activities associated with administration and compliance. Health Canada anticipates that its compliance and enforcement program costs would be $6,677,430 over a 10-year period. The total costs would translate to a present value cost (discounted by 7%) of $10,362,879 over a 10-year period.

Benefits

Qualitative benefits

The objective of the proposed safety framework for donor sperm and ova in Canada is to reduce the risks to human health and safety that arise from using donor sperm and ova for the purpose of AHR, including the risk of disease transmission. Based on the precautionary principle, the health and safety oversight of donor sperm and ova requires modernization to address emerging diseases, changes in the industry, genetic diseases, as well as the addition of requirements for donor ova.

Through a document incorporated by reference, the proposed Safety of Sperm and Ova Regulations would indicate the infectious diseases for which a sperm or ova donor would need to be screened and tested prior to donation. The proposed Regulations would also require additional genetic disease screening of prospective donors by requiring them to undergo a questionnaire to help determine the presence of known genetic diseases in the donor or in their family history. This would help mitigate the risk of genetic disease transmission to donor-conceived children. It is believed that existing establishments in Canada currently meet these requirements.

The testing requirements being proposed are justifiable, as Health Canada relies on the precautionary principle when it comes to the prevention of disease transmission. While the CBA does not attempt to quantify the benefits of avoided disease transmission due to the difficulty in estimating potential reductions, an example is provided to illustrate the type of benefit that could result from these reductions. Health Canada has analyzed the costs associated with the avoidance of one specific infectious disease that could be transmitted (hepatitis C) to determine a baseline for current expenses being carried. These savings in expenses only measure the current spending on hepatitis C; however, there are other similar diseases that could be used in this analysis such as the West Nile virus or HIV, among others. Looking at hepatitis C specifically as an example disease, a study estimated the lifetime cost for a patient with chronic hepatitis C at $64,694 in 2013, noting that this cost varied substantially according to the state of the disease, ranging from a low-cost scenario of $51,946 for a patient with no fibrosis, to a high-cost scenario of $327,608 for a patient requiring a liver transplantation. ^{footnote 18} The study also noted that while the prevalence of chronic infection with hepatitis C in Canada is projected to decrease, advanced liver disease and associated costs are projected to continue to rise over the next 20 years. Preventing disease transmissions would result in benefits to the health care system due to these avoided costs.

Quantitative benefits

Table 5: Reduced Health Canada costs by ending the Donor Semen Special Access Programme

	Year 1	Years 2–10	Average	Total (PV)
Reduced DSSAP costs	$14,800	$14,800	$14,800	$103,949

Currently, through the Donor Semen Special Access Programme (DSSAP) in the Semen Regulations, doctors can apply to the Minister of Health to obtain access to non-compliant sperm. The Minister of Health currently has the authority to grant or refuse each special access application. Under the proposed Regulations, an application to the Minister of Health would not be a requirement for the proposed replacements to the DSSAP: the directed donation process and exceptional access. It is anticipated that health professionals would spend the same amount of time to prepare documents for the directed donation process and exceptional access as they currently do for the DSSAP, as the documentation requirements are similar. The reduction in mailing costs resulting from the elimination of an application requirement would be negligible. As a result, no reduction in costs for health professionals has been estimated.

It is anticipated that ending the DSSAP would reduce program costs for Health Canada. In 2017, under the DSSAP, the Minister of Health received 74 applications. Health Canada estimates that each application costs the Department approximately $200 to review, authorize and file. The Department would thus save approximately $14,800 annually by eliminating the need to review and authorize applications under the DSSAP, which represents a present value benefit of $103,949 over the same 10 years, discounted at 7%.

Small business lens

The small business lens applies to regulatory proposals that affect small business and would impose a nationwide cost over $1 million annually. The Treasury Board Secretariat defines a small business as any business, including its affiliates, which has fewer than 100 employees or between $30,000 and $5 million in annual gross revenues. Health Canada anticipates that all establishments in the AHR industry would be considered small businesses. As a result, there are approximately 105 small businesses operating in Canada that could be affected by the regulatory proposal.

Regulatory Flexibility Analysis Statement

Health Canada considered two options for how establishments would be required to inform the Department of their activities, when developing the health and safety framework for donor sperm and ova. The first option considered was registration for all establishments that process, import, or distribute donor sperm and ova. The second option, which was selected, would only require registration for establishments that are responsible for conducting all processing activities with regard to donor sperm and ova. Establishments that import or distribute donor sperm and ova would need to instead notify Health Canada prior to commencing these activities. As notification is less administratively burdensome than registration, establishments that distribute or import donor sperm or ova would save on costs by having only to notify rather than register with Health Canada.

The second option was selected because it would achieve the objective of providing safety oversight on establishments participating in Canada's donor sperm and ova supply chain without unduly imposing unnecessary administrative burden costs on Canadian small businesses. Further, under this option, health professionals who are not undertaking activities that are performed by primary establishments or establishments that import or distribute donor sperm or ova would not be required to register or notify Health Canada.

The selected option would place the most regulatory oversight and administrative burden upstream in the supply chain on those establishments responsible for the activities that bear the most health risk (i.e. screening and testing of sperm and ova donors). Regulatory oversight and administrative burden would decrease down the supply chain commensurate with the level of health risk associated with each activity, as regards the safety of donor sperm and ova.

The alternative option that was not selected would require all establishments to register with Health Canada, no matter what activities they engaged in along the supply chain. This option would also have required health professionals conducting activities that are not reserved for establishments to register with Health Canada and be subject to all of the same regulatory requirements as a primary establishment. This option would have imposed significant compliance and administrative burden on health professionals, even when they would have been only making use of donor sperm or ova.

Ultimately, the second option was selected because it reduces burden on small business where possible without compromising the safety oversight objective of the framework.

Table 6: Comparison of alternate and chosen options for registration, notification and related requirements

	Alternate Option	Chosen Option
Short description	Registration for all establishments and health professionals	Registration of primary establishments and notification for establishments that import or distribute
	Average costs for all establishments and health professionals ($)	Average costs for primary establishments and establishments that import or distribute ($)	Average costs for establishments that perform processing activities and health professionals ($)
Compliance cost — Registration/Notification	$113 one-time cost	$113 one-time cost	$0
	Average costs for all establishments and health professionals ($)	Average costs for primary establishments and establishments that import or distribute ($)	Average costs for establishments that perform processing activities and health professionals ($)
Compliance cost — Annual statement	$103 annually	$103 annually	$0
Administrative cost — Amend or change data	$34 annually	$34 annually	$0
Total cost per small business	Year 1: $250 Years 2–10: $137	Year 1: $250 Years 2–10: $137	$0

"One-for-One" Rule

The current initiative is an "IN" ("One-for-One" Rule).

Annualized administrative costs (constant $2012)	$49,974
Annualized administrative costs per business ($2012)	$476

The "One-for-One" Rule applies to the regulatory proposal, and the anticipated administrative burden to establishments is estimated to be $49,974 (2012 dollars) annually. This calculation includes costs associated with record keeping, information requests, record retrieval, amending or changing data, and reporting errors, accidents and adverse reactions. The cost estimates associated with the "One-for-One" Rule are reported in 2012 dollars and discounts values to a base year of 2012.

As a way to partially reduce the administrative burden on industry, Health Canada is proposing to allow those establishments that only import or distribute sperm and ova to be required to notify Health Canada before they commence these activities, rather than having to register with Health Canada. As registration is a somewhat more administratively burdensome process than notification, this would have the effect of reducing the administrative burden on those establishments that only engage in importation and distribution of donor sperm and ova.

This proposal would create three new sets of regulations and repeal one set of regulations. Two of the new sets of regulations (safety, and reimbursement) would impose administration burden and so would be considered "IN" regulatory titles under the "One-for-One" Rule. The repeal of the Semen Regulations would be considered an "OUT" regulatory title. Overall, this proposal would result in a total "IN" of one regulatory title, and it would carry the obligation under the Red Tape Reduction Act to repeal an additional regulatory title within the next two years from within the health portfolio, unless a regulation has already been repealed in accordance with that Act at the time the new regulations are made.

Gender-based Analysis Plus

While all persons may be affected by the use of AHR technologies, the AHRA itself notes that women who use donated sperm or ova, women who act as surrogates, and children born as a result of the use of these technologies are more directly and significantly impacted by their application than men. Gender and diversity issues were initially assessed as part of the original legislative process surrounding the AHRA.

Gender and diversity issues were also considered during regulatory development based on feedback received from diverse stakeholder groups during policy consultations. It is recognized that women using AHR technologies and children born of AHR face an increased health risk due to existing safety gaps in Canada's regulatory framework. The proposed Safety of Sperm and Ova Regulations would help to reduce this risk with the introduction of safety requirements for donor ova and improved safety requirements of donor semen.

The proposed Regulations would also benefit Canadians using donor sperm through the inclusion of the proposed directed donation process that would give a person more flexibility in choosing a donor by making it less administratively burdensome for a person (such as a single woman or a woman in a same-sex couple) wanting to make use of a friend's sperm in AHR.

The proposed Reimbursement Related to Assisted Human Reproduction Regulations would put clear rules in place in respect of reimbursement that would provide clarity for sperm or ova donors and surrogate mothers who want to be reimbursed for expenditures permitted under the Act.

The proposed Regulations on the Administration and Enforcement of the Assisted Human Reproduction Act would support the bringing into force of the administration and enforcement sections of the AHRA. With these sections in force, Health Canada would be better able to administer and enforce the Act and help protect persons affected by the use of AHR technologies, especially women using these technologies and children born as a result of the use of these technologies.

Consultation

There is a range of stakeholders who may be impacted by or have views on the proposed regulations. This includes people in Canada using AHR technologies and children born through AHR; fertility clinics; donor sperm and ova processors such as sperm and ova banks; donor sperm and ova importers and distributors; businesses that provide surrogacy consulting services and arrange sperm and ova donations; professional associations; advocacy and rights associations including LGBTQ2 groups; health care providers (e.g. doctors performing AHR in clinical settings); lawyers specializing in fertility law / family law; provinces and territories; and academics.

A notice of intent to introduce regulations under the AHRA was published in October 2016. Subsequently, Health Canada published a consultation paper in July 2017 and launched a 60-day consultation period that generated 57 sets of comments. Comments were submitted by a range of stakeholders, including individuals as well as representatives of medical professionals, the AHR industry, academics, surrogates, intended parents, advocacy groups, and fertility lawyers. A summary of the feedback received was published in January 2018.

In general, there is stakeholder support for developing regulations under the AHRA to help protect the health and safety of persons who use AHR technologies or are born through AHR. Many stakeholders emphasized the point that the proposed regulatory scheme under the AHRA should recognize the important role that a health care provider plays in assessing and communicating risks to persons using AHR technologies and should leave room for AHR recipients to make their own decisions about risks in certain circumstances.

Stakeholders were generally supportive of the registration and notification schemes being proposed, but were divided as to who should bear which obligations. Most stakeholders agreed with Health Canada's proposed approach to place the highest level of regulatory oversight on those establishments responsible for processing donations, due to the human health and safety risks associated with their activities. While most stakeholders were of the view that the processing of donations where the donor is known to the recipient (directed donation) should be subject to the same regulatory oversight as the processing of anonymous donations, some stakeholders felt it would be appropriate for directed donations to be subject to fewer regulatory obligations. Health Canada agrees with the majority of stakeholders and recognizes that the human health and safety risks associated with the processing of donor sperm and ova merit a similar level of oversight in both circumstances. Similarly, some stakeholders felt that proposed regulatory requirements in respect of personnel, facilities, equipment, and quality management should be equally applicable to all persons engaged in regulated activities, while other stakeholders did not, as they felt the operational and economic burden of complying could be too great to bear.

The majority of stakeholders agreed with Health Canada's proposed approach to sperm and ova donor screening, testing and donor suitability assessment, and supported the proposed directed donation pathway. For instance, stakeholders agreed with the proposed genetic screening criteria for sperm and ova donors, and were in support of the embedded flexibility to assess a donor based on genetic diseases known to be prevalent in the donor's ethnic background, in accordance with recognized medical guidelines. Some stakeholders suggested additional infectious disease testing, such as testing for "new or emerging infections," while other industry stakeholders expressed concern with respect to the availability or accessibility of certain tests, or their relevance in particular geographic regions of Canada. Some also raised concern about the cost and reliability of a few of the currently available tests. Health Canada took into consideration all feedback provided and has made some revisions to the infectious disease testing requirements as a result. For instance, this included revising the testing requirement for West Nile virus so it is done when relevant, rather than year-round. Specifically, it would be required only if the donation is made during the time of year when the virus is potentially transmissible to humans, or if the donor has lived in or travelled to an area where the virus was recently endemic.

Many stakeholders indicated support for the proposed categories of reimbursement expenditures, but some suggested additions and modifications to those categories with a view to ensuring the regulations are flexible enough to accommodate the individual circumstances of each donation and surrogacy situation. Health Canada has assessed all of the feedback provided and made modifications to the categories of expenditures, as appropriate.

Health Canada also received a number of comments that were out of the scope of the regulatory project. These included comments calling on the Government to amend the AHRA to remove the prohibitions on payment to sperm and ova donors and to surrogates, to review the scientific prohibitions and to decriminalize certain aspects of the Act. While these stakeholders advocated for making legislative changes at the level of the AHRA, most were in support of advancing the regulatory project, recognizing the importance of bringing into force the remaining sections of the Act.

In addition to comments received through formal consultations, several stakeholder groups, including provincial and territorial counterparts as well as those representing AHR health care providers and associations, have been generally supportive of the Government's intent to make regulations and bring into force the dormant sections of the AHRA. Some cite the continued importance of the legislation and the fact that action is overdue. Specifically, stakeholders supported Health Canada in addressing the regulatory gaps that have resulted from the outdated Semen Regulations and lack of donor ova regulations. These stakeholders also stressed the importance of having a reimbursement system that is not overly onerous or bureaucratic and advocated for a model that would allow for reasonable compensation, suggesting that a definitive itemized list of reimbursable expenses could be too rigid to account for the individual circumstances of each donation and surrogacy arrangement.

Regulatory cooperation

Though regulatory alignment is not the purpose of the proposal, this proposal would increase overall alignment between Canada and the United States, the source of the majority of donor sperm and ova used in Canada. The proposed registration scheme in the Safety of Sperm and Ova Regulations would be similar to what is in place in the United States. Donor sperm and ova in the United States are regulated under Title 21 of the Code of Federal Regulations, part 1271, entitled Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps). U.S. regulations require that all establishments that process or distribute donor sperm and ova for use in the United States must register with the Food and Drug Administration (FDA) and comply with the associated regulations. In addition, establishments located outside of the United States that import, or offer for import, donor sperm and ova into the United States are required to register with the FDA. ^{footnote 19}

The proposed Safety of Sperm and Ova Regulations would closely align the screening and testing requirements for sperm and ova donors with those in the United States. Specifically, compared to the current requirements in the Semen Regulations, the proposal would result in greater alignment of infectious disease testing requirements, test kit requirements, and donor deferral requirements. For example, this includes permitting the use of test kits licensed in the United States as well as better aligning infectious disease testing intervals with those currently required in the United States.

Where the proposed Regulations would not align with regulations in the United States or Europe, the Canadian requirements are not expected to pose an additional burden. For example, while there is no requirement under HCT/Ps regulations for donors of sperm or ova to undergo genetic screening, it is typical industry practice for donors to undergo genetic testing that would satisfy the proposed regulatory requirements of genetic screening. Similarly, in Europe, sperm and ova donors are required to be screened for genetic diseases prevalent in their ethnic background and other inherited conditions known to be present in the family, as outlined in the European Union Tissue and Cells Directives (EUTCD). While the EUTCD defines overarching mandatory requirements for donors of reproductive tissues, it also allows for European Union member states to adopt their own specific genetic screening and/or genetic testing requirements on a national basis to address local epidemiological risk factors and to ensure a higher level of safety. The proposed requirements related to genetic screening would result in Canadian requirements being better aligned with typical industry practice in the United States and Europe than is the case under the current regulatory requirements in the Semen Regulations.

The existing Consent Regulations align with typical industry practice in the United States, and the proposed amendments would resolve concerns of sperm and ova banks, including those in the United States, that the Regulations could unintentionally compromise the anonymity of donors. As payment for sperm and ova donation and surrogacy is not prohibited in the United States, there are no regulatory requirements in the United States with respect to reimbursement of expenditures. However, Canadian regulations with respect to reimbursement are necessary to bring into force the reimbursement provisions of the AHRA. Having different regimes is not expected to pose any issues regarding regulatory alignment.

Rationale

Protecting Canadians who use donor sperm and ova in AHR

The proposed Safety of Sperm and Ova Regulations would help protect the health and safety of Canadians who use donor sperm and ova and the children born through AHR by updating the screening and testing requirements for donor sperm and by introducing screening and testing requirements for donor ova. This would include modernizing the requirements for donor sperm by updating donor screening criteria to reflect advances in the understanding of disease pathology, and by changing donor testing requirements, including expanding test kit eligibility and increasing testing intervals. The proposed framework would also increase oversight of the establishments that supply donor sperm and ova to better support the use of sperm and ova that meet safety requirements.

While the proposed Regulations would have a net present value cost of $10,258,930 over a 10-year period, with a $3,685,449 cost to industry and the remainder to the federal government, the qualitative benefits in human health and safety, including reducing the risk of disease transmission to recipients of donor sperm and ova as well as children born of AHR, warrant the requirements.

Permitting reimbursements to donors and surrogate mothers

The proposed Reimbursement Related to Assisted Human Reproduction Regulations would provide clarity on the permitted expenditures that may be reimbursed to sperm and ova donors and surrogate mothers, as well as to persons involved in maintaining and transporting IVEs. This would provide needed clarity to those offering and receiving reimbursements related to these AHR activities so they could undertake those transactions without concerns that they could be contravening the Act.

Improving accessibility of donations

The proposed Safety of Sperm and Ova Regulations would better align with U.S. FDA regulations as well as typical U.S. industry practice by better aligning donor screening and deferral requirements, infectious disease testing requirements, including testing intervals, and test kit requirements. As the majority of donor sperm and ova used in Canada are processed in the United States, this may have a positive impact on their availability. In addition, the proposed regulatory oversight will allow for more flexibility in processing donations from establishments in other jurisdictions, considering the requirement that donor sperm or ova may be imported as long as it is processed by a primary establishment that is registered in accordance with the proposed Regulations. Further, directed donation processing will make it easier for Canadians who know their donor to proceed with building their families.

Implementation, enforcement and service standards

The coming into force of the regulations would be gradual to provide time for stakeholders to plan for and adjust to the new regulatory requirements, and to give Health Canada time to update its processes. Transitional provisions would provide regulated parties that process, import, or distribute donor sperm or ova with a 90-day period after the coming into force of the Safety of Sperm and Ova Regulations to comply with the registration and notification provisions. Health Canada would also develop guidance documents to provide assistance to the AHR industry on how to comply with the regulations.

Compliance and enforcement activities in support of the new regulatory requirements may begin after publication of the regulations in the Canada Gazette, Part II. Health Canada's compliance approach to the Safety of Sperm and Ova Regulations would be in line with the approach currently used for the Semen Regulations and other regulatory regimes. With regard to service standards for responding to registrations from primary establishments, it is expected that, after the transitional period, 90% of decisions would be made within 90 calendar days from the receipt of a complete application.

Compliance and enforcement activities may include the following: monitoring establishment compliance through a risk-based inspection program; compliance verification and investigation activities based on complaints or identified non-compliance with the regulations; and education, consultation and information sharing through the development of documents and other compliance promotion activities.

Performance measurement and evaluation

Health Canada would implement the program evaluation requirements of the Treasury Board Policy on Results with respect to certain elements of this proposal (i.e. safety of semen and ova, reimbursement) through the Health Product Performance Measurement Strategy, the results-based management tool that measures, monitors and reports on expected results of the Health Products Program. As part of this strategy, Health Canada would incorporate proactive compliance promotion, monitoring and data collection following the implementation period to determine whether there are any trends associated with non-compliance that could suggest that sections of the regulations are not understood by all or particular groups of regulated parties.

Contact

Bruno Rodrigue
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower A, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca

Small Business Lens Checklist

1. Name of the sponsoring regulatory organization:

2. Title of the regulatory proposal:

3. Is the checklist submitted with a RIAS for the Canada Gazette, Part I or Part II?

☑ Canada Gazette, Part I ☐ Canada Gazette, Part II

A. Small business regulatory design

I	Communication and transparency	Yes	No	N/A
1.	Are the proposed regulations or requirements easily understandable in everyday language?	☑	☐	☐
2.	Is there a clear connection between the requirements and the purpose (or intent) of the proposed regulations?	☑	☐	☐
3.	Will there be an implementation plan that includes communications and compliance promotion activities, that informs small business of a regulatory change and guides them on how to comply with it (e.g. information sessions, sample assessments, toolkits, websites)?	☑	☐	☐
4.	If new forms, reports or processes are introduced, are they consistent in appearance and format with other relevant government forms, reports or processes?	☑	☐	☐
II	Simplification and streamlining	Yes	No	N/A
1.	Will streamlined processes be put in place (e.g. through BizPaL, Canada Border Services Agency single window) to collect information from small businesses where possible?	☐	☑	☐
The proposed information collection has been designed to reduce burden on businesses where possible, including placing fewer requirements on regulated parties that perform lower-risk activities. The proposed requirements do not require the services provided by BizPal, the Single Window Initiative, or similar streamlined processes.
2.	Have opportunities to align with other obligations imposed on business by federal, provincial, municipal or international or multinational regulatory bodies been assessed?	☑	☐	☐
3.	Has the impact of the proposed regulations on international or interprovincial trade been assessed?	☑	☐	☐
4.	If the data or information, other than personal information, required to comply with the proposed regulations is already collected by another department or jurisdiction, will this information be obtained from that department or jurisdiction instead of requesting the same information from small businesses or other stakeholders? (The collection, retention, use, disclosure and disposal of personal information are all subject to the requirements of the Privacy Act. Any questions with respect to compliance with the Privacy Act should be referred to the department's or agency's ATIP office or legal services unit.)	☐	☐	☑
The specific information that would be collected under the proposed regulations is not being collected by another department or jurisdiction.
5.	Will forms be pre-populated with information or data already available to the department to reduce the time and cost necessary to complete them? (Example: When a business completes an online application for a licence, upon entering an identifier or a name, the system pre-populates the application with the applicant's personal particulars such as contact information, date, etc. when that information is already available to the department.)	☐	☑	☐
Health Canada's long-term plan would be to accommodate the above scenarios; however, there are currently no processes in place to support this.
6.	Will electronic reporting and data collection be used, including electronic validation and confirmation of receipt of reports where appropriate?	☑	☐	☐
7.	Will reporting, if required by the proposed regulations, be aligned with generally used business processes or international standards if possible?	☑	☐	☐
8.	If additional forms are required, can they be streamlined with existing forms that must be completed for other government information requirements?	☑	☐	☐
III	Implementation, compliance and service standards	Yes	No	N/A
1.	Has consideration been given to small businesses in remote areas, with special consideration to those that do not have access to high-speed (broadband) Internet?	☑	☐	☐
2.	If regulatory authorizations (e.g. licences, permits or certifications) are introduced, will service standards addressing timeliness of decision making be developed that are inclusive of complaints about poor service?	☑	☐	☐
3.	Is there a clearly identified contact point or help desk for small businesses and other stakeholders?	☑	☐	☐

B. Regulatory flexibility analysis and reverse onus

IV	Regulatory flexibility analysis	Yes	No	N/A
1.	Does the RIAS identify at least one flexible option that has lower compliance or administrative costs for small businesses in the small business lens section? Examples of flexible options to minimize costs are as follows: Longer time periods to comply with the requirements, longer transition periods or temporary exemptions; Performance-based standards; Partial or complete exemptions from compliance, especially for firms that have good track records (legal advice should be sought when considering such an option); Reduced compliance costs; Reduced fees or other charges or penalties; Use of market incentives; A range of options to comply with requirements, including lower-cost options; Simplified and less frequent reporting obligations and inspections; and Licences granted on a permanent basis or renewed less frequently.	☑	☐	☐
2.	Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, quantified and monetized compliance and administrative costs for small businesses associated with the initial option assessed, as well as the flexible, lower-cost option?	☑	☐	☐
3.	Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, a consideration of the risks associated with the flexible option? (Minimizing administrative or compliance costs for small business cannot be at the expense of greater health, security or safety or create environmental risks for Canadians.)	☐	☐	☑
The flexible option introduces no additional risks.
4.	Does the RIAS include a summary of feedback provided by small business during consultations?	☑	☐	☐
V	Reverse onus	Yes	No	N/A
1.	If the recommended option is not the lower-cost option for small business in terms of administrative or compliance costs, is a reasonable justification provided in the RIAS?	☐	☐	☑

N/A, as the recommended option is the lower cost option.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 65 ^{footnote a} of the Assisted Human Reproduction Act ^{footnote b}, proposes to make the annexed Safety of Sperm and Ova Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, Address Locator: 3000A, 11 Holland Avenue, Suite 14, Ottawa, Ontario K1A 0K9 (email: hc.lrm.consultations-mlr.sc@canada.ca).

Ottawa, October 18, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

Safety of Sperm and Ova Regulations

Interpretation

Definitions

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

• accident means an unexpected event that is not attributable to a deviation from the standard operating procedures or applicable laws, including these Regulations and that could compromise human health and safety or the safety of sperm or ova. (accident)
• activity, in respect of sperm or ova, means any of the following activities:
  • (a) processing, which includes
    • (i) performing the donor suitability assessment,
    • (ii) obtaining the sperm or ova from a donor,
    • (iii) preparing,
    • (iv) identifying,
    • (v) testing,
    • (vi) preserving,
    • (vii) assessing quality,
    • (viii) labelling,
    • (ix) quarantining, or
    • (x) storing;
  • (b) distributing;
  • (c) importing. (activité)
• adverse reaction means the unexpected presence of an infectious disease agent or the unexpected occurrence of an infectious disease in a recipient of sperm or ova or a child created from that sperm or those ova. (effet indésirable)
• Directive means the document entitled Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors, published by the Department of Health, as amended from time to time. (Directive)
• donation code means the unique group of numbers, letters, symbols or a combination of any of them that identifies the sperm or ova donation. (code d'identification du don)
• donor identification code means the unique group of numbers, letters, symbols or a combination of any of them that is assigned to a donor. (code d'identification du donneur)
• donor suitability assessment means an assessment of a donor that is based on the following:
  • (a) donor screening;
  • (b) physical examination of the donor; and
  • (c) donor testing. (évaluation de l'admissibilité du donneur)
• error means a deviation from the standard operating procedures or applicable laws, including these Regulations, that could compromise human health and safety or the safety of sperm or ova. (manquement)
• establishment means a person, partnership, unincorporated entity or a part of any of them that conducts an activity but only includes a health professional if he or she conducts an activity that is not referred to in the definition health professional. (établissement)
• health professional means a person who is authorized under the laws of a province to make use of sperm or ova in that province and who
  • (a) makes use of sperm or ova or distributes sperm to a recipient for their personal use;
  • (b) prepares, quarantines, labels or stores sperm or ova for the purpose of their use by that person; or
  • (c) prepares, quarantines, labels or stores sperm for the purpose of its distribution by that person to a recipient for their personal use. (professionnel de la santé)
• human health and safety means the health and safety of a recipient of sperm or ova or a child created from that sperm or those ova to the extent that their health and safety relate to the safety of the sperm or ova. (santé et sécurité humaines)
• medical director, in respect of a primary establishment, means a person who is authorized under the laws of the jurisdiction in which the primary establishment is situated to practise the profession of medicine and who is responsible for all medical and technical procedures carried out during the processing of sperm or ova. (directeur médical)
• primary establishment means an establishment that conducts all processing activities in respect of sperm or ova, whether it conducts them itself or another establishment conducts any of the activities on its behalf. (établissement principal)
• quarantine, with respect to sperm and ova, means the quarantine described in section 28. (mise en quarantaine)
• standard operating procedures means the component of a quality management system that comprises instructions that set out the processes applicable to the components of the system and to the activities carried out by an establishment. (procédures d'opération normalisées)

Amendments to Directive

(2) The document referred to in the definition of Directive is deemed to be amended for the purposes of these Regulations if the amendment is not inconsistent with the purpose of reducing risks to human health and safety.

General Requirements

Primary establishment — conformity of processing

2 (1) A primary establishment must ensure that sperm or ova are processed in accordance with these Regulations before distributing or making use of them.

Primary establishment — activities on its behalf

(2) The primary establishment must ensure that every establishment that conducts any processing on its behalf meets the requirements of these Regulations.

Establishment that imports

3 An establishment that imports sperm or ova must ensure that the sperm or ova are processed by a primary establishment that is registered in accordance with these Regulations.

Registration and Notification

Registration

Application, Issuance and Refusal

Requirement to register — primary establishment

4 A primary establishment that processes sperm or ova must be registered and may process sperm or ova, subject to any change under paragraph 11(1)(a), only in accordance with its registration.

Application

5 (1) A primary establishment must submit an application for registration to the Minister, in the form established by the Minister, that contains the following information:

• (a) the applicant's name, telephone number, email address, postal address and, if different from the postal address, civic address;
• (b) in the case of an applicant 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 application and, if different, a person to contact in case of emergency;
• (d) a statement indicating whether the applicant proposes to process sperm or ova;
• (e) a list of the processing activities that the applicant proposes to conduct in each building and, if not already provided, the civic address of the respective buildings;
• (f) a statement indicating whether the applicant proposes to have another establishment process sperm or ova on its behalf; and
• (g) the name and civic address of any other establishment that the applicant proposes to have conduct any of the processing activities on its behalf, a list of the processing activities that are proposed to be conducted in each building and, if not already provided, the civic address of the respective buildings.

Signature and attestation

(2) The application 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 applicant has evidence demonstrating that it is able to meet the requirements of these Regulations,
  • (ii) that any other establishment that is proposed to process sperm or ova on its behalf is able to meet the requirements of these Regulations,
  • (iii) that all information submitted in support of the application is accurate and complete, and
  • (iv) that the senior executive officer has the authority to bind the applicant.

Additional documents and information

(3) The applicant must provide to the Minister, on or before the date specified in the Minister's written request to that effect, any documents or information that the Minister considers necessary to complete his or her review of the application.

Registration number

6 If the Minister determines, after reviewing an application for registration, that the information provided in the application is complete, the Minister must register the primary establishment and issue a registration number.

Refusal

7 The Minister may refuse to register an applicant if :

• (a) the Minister has reasonable grounds to believe that the applicant has submitted, in the application for registration, false, misleading, inaccurate or incomplete information;
• (b) the applicant has not complied with subsection 5(3) or the documents and information that the applicant has provided under subsection 5(3) are not sufficient to complete the review of the application; or
• (c) the Minister has reasonable grounds to believe that registering the primary establishment could compromise human health and safety or the safety of sperm or ova.

Amendments

Amendments — application

8 (1) A primary establishment that processes only one of sperm or ova and proposes to begin processing the other must, before doing so, submit an application to the Minister to amend its registration, in the form established by the Minister, that contains a description of the proposed amendment, as well as the information referred to in section 5 that is relevant to the proposed amendment.

Signature and attestation

(2) The application 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 applicant has evidence demonstrating that it is able to meet the requirements of these Regulations,
  • (ii) that any other establishment that is proposed to process sperm or ova on its behalf is able to meet the requirements of these Regulations,
  • (iii) that all information submitted in support of the application is accurate and complete, and
  • (iv) that the senior executive officer has the authority to bind the applicant.

Additional documents and information

(3) The primary establishment must provide to the Minister, on or before the date specified in the Minister's written request to that effect, any documents or information that the Minister considers necessary to complete his or her review of the application.

Amendment

9 If the Minister determines, after reviewing the application for the amendment to the registration, that the information provided in that application is complete, the Minister must amend the registration.

Refusal

10 The Minister may refuse to amend the registration of the primary establishment if :

• (a) the Minister has reasonable grounds to believe that the primary establishment has submitted, in the application for amendment, false, misleading, inaccurate or incomplete information;
• (b) the primary establishment has not complied with subsection 8(3) or the documents and information that they have provided under subsection 8(3) are not sufficient to complete the review of the application; or
• (c) the Minister has reasonable grounds to believe that the amendment of the registration could compromise human health and safety or the safety of sperm or ova.

Changes or Cessation

Notice to Minister

11 (1) A primary establishment must notify the Minister in writing, in the form established by the Minister, within 30 days after the day on which :

• (a) there is any change to the information provided in the application for registration — other than a change that is the subject of an application for an amendment to the registration — including the cessation of all activities with respect to either sperm or ova if the registration is for both sperm and ova; or
• (b) the primary establishment has ceased all of its activities.

Contents of Notice

(2) The notice must contain the following information:

• (a) the primary establishment's name, telephone number, email address, postal address and, if different from the postal address, civic address;
• (b) the primary establishment's registration number;
• (c) the date on which the change or cessation became effective; and
• (d) in the case of cessation, details of the disposition of the sperm or ova that are in the possession or control of the primary establishment.

Signature and attestation

(3) 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 if the primary establishment has not ceased all of its activities, it has evidence demonstrating that it meets the requirements of these Regulations,
  • (ii) that if the primary establishment has not ceased all of its activities, any other establishment that processes sperm or ova or is proposed to process sperm or ova on its behalf meets the requirements of these Regulations,
  • (iii) that all information submitted in support of the notice is accurate and complete, and
  • (iv) that the senior executive officer has the authority to bind the primary establishment.

Update to registration

12 The Minister must update the registration to reflect the notice.

Suspension

Urgent circumstances

13 (1) The Minister may suspend, in whole or in part, without prior notice, a primary establishment's registration, if he or she has reasonable grounds to believe that human health and safety or the safety of the sperm or ova has been or could be compromised.

Notice

(2) If the Minister suspends a registration, the Minister must send a notice to the primary establishment that

• (a) gives the reasons for the suspension 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.

Action following suspension of registration

(3) On the suspension of its registration, the primary establishment must immediately notify every establishment, health professional or recipient to which it has distributed the implicated sperm or ova during the period specified in the notice of the reasons for its suspension, the effective date of the suspension and the parts of the registration that are the subject of the suspension.

Action upon notice

(4) An establishment that has been notified under subsection (3) or under this subsection must immediately notify to the same effect any establishment, health professional or recipient to which it distributed the implicated sperm or ova.

Written notice

(5) If the Minister or the establishment gives a notice verbally under this section, that notice must be confirmed in writing as soon as feasible .

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.

Notice

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

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.

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

Cessation of activities

15 The Minister must cancel a registration if he or she 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

Circumstances

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

• (a) the primary establishment has not provided the annual statement 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.

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.

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.

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.

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

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.

Signature and attestation

(2) The notice must

• (a) be signed and dated by a senior executive officer;
• (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) all information submitted in support of the notice is accurate and complete, and
  • (iii) the senior executive officer has the authority to bind the establishment.

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.

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) all information submitted in support of the notice is accurate and complete, and
  • (iii) the senior executive officer has the authority to bind the establishment.

Annual Attestation

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.

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.

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

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.

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".

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".

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".

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".

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.

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.

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

Identification and segregation

28 An establishment must quarantine all sperm and ova that it processes in the following manner:

• (a) clearly identifying the sperm and ova as quarantined;
• (b) segregating the sperm and ova from sperm and ova that are not quarantined; and
• (c) ensuring that the sperm and ova are not distributed.

Retesting sperm donors — requirement

29 (1) A primary establishment must ensure that a sperm donor who has been determined to be suitable is retested.

Retesting — Directive

(2) An establishment that retests a sperm donor must do so in accordance with the requirements set out in the Directive under the heading "Donor Retesting".

Release from quarantine

30 An establishment that quarantines sperm and ova must do so 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;
• (b) determined that the requirements set out in the Directive under the heading "Donor Retesting" have been met; and
• (c) determined and documented that the sperm and ova can be released from quarantine.

Release from quarantine — exceptional access

31 (1) Despite paragraphs 30(a) and (b), an establishment may release sperm or ova from quarantine if the primary establishment that is responsible for their quarantine receives from a health professional a request 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 from that donor that was retested at the same time as the sperm that is requested;
• (b) the recipient has previously been exposed to ova from that donor that were obtained on the same day as the ova that are requested;
• (c) 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 .

Summary document

(2) Before the sperm or ova are released from quarantine, the primary establishment must ensure that its medical director creates 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;
• (d) the reasons the donor was determined to be unsuitable and a detailed explanation for each reason; and
• (e) a list of any requirements set out in the Directive under the heading "Donor Retesting" that have not been met.

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.

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 his or her 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 he or she has informed the recipient of the risks that the use of the sperm or ova could pose to human health and safety and that he or she has obtained written consent from the recipient.

Directed Donation Process

Donor Suitability Assessment and Confirmation

Application

32 Despite sections 22 to 31, the requirements set out in sections 33 to 43 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.

Donor suitability assessment

33 A primary establishment, in the context of a directed donation, must ensure that a donor suitability assessment is conducted.

Donor screening

34 An establishment that performs donor screening, in the context of a directed donation, must do so in accordance with the requirements set out in the Directive under the heading "Donor Screening".

Physical examination

35 An establishment that performs physical examinations on donors, in the context of a directed donation, must do so in accordance with the requirements set out in the Directive under the heading "Physical Examination".

Donor testing

36 An establishment that performs donor testing, in the context of a directed donation, must do so in accordance with the requirements set out in the Directive under the heading "Donor Testing".

Donor reassessment

37 A primary establishment, in the context of a directed donation, must ensure that a repeat donor is reassessed in accordance with the requirements set out in the Directive under the heading "Donor Reassessment".

Review by primary establishment

38 (1) A primary establishment, in the context of a directed donation, must ensure that its medical director reviews the information obtained from the donor suitability assessment and, if applicable, the donor reassessment.

Summary document

(2) A primary establishment must ensure that its medical director creates and signs a summary document that confirms the review 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;
• (c) the dates and results of the donor testing and the assessment of the risk of genetic disease transmission; and
• (d) a list of any criteria set out in the Directive under the heading "Donor Exclusion" that have been met.

Donor suitability assessment cannot be conducted

39 (1) Despite sections 33, 37 and 38, a primary establishment, in the context of a directed donation, must ensure that its medical director meets the requirements set out in subsection (2) if

• (a) a donation of sperm or ova has previously been obtained from the donor;
• (b) the donor suitability assessment in respect of the donation was not conducted in accordance with these Regulations; and
• (c) it is not medically possible to obtain another donation of sperm or ova from the donor or obtaining another donation of sperm or ova would pose a serious risk to the donor.

Requirements

(2) The medical director must meet the following requirements :

• (a) review any available medical information about the donor;
• (b) review any available results of any donor screening, physical examination or donor testing that was previously conducted;
• (c) unless it is not medically possible to do so, take appropriate measures to complete the donor suitability assessment; and
• (d) create a summary document that confirms the medical director's review and that contains
  • (i) the age of the donor,
  • (ii) the medical reasons for which another donation cannot be obtained or an explanation of the risk,
  • (iii) the dates and results of any donor screening, physical examination or donor testing,
  • (iv) a list of any criteria set out in the Directive under the heading "Donor Exclusion" that have been met, and
  • (v) a list of any parts of the donor suitability assessment that have not been conducted and, for each one, an explanation of the reasons it was not conducted.

Quarantine

Identification and segregation

40 An establishment that processes sperm or ova in the context of directed donation must quarantine that sperm or those ova.

Release from quarantine

41 An establishment that quarantines sperm and ova in the context of a directed donation must do so until the medical director of the primary establishment that is responsible for the quarantine of that sperm and those ova has

• (a) confirmed the review of the donor suitability assessment; and
• (b) determined and documented that the sperm and ova can be released from quarantine.

Storage

42 An establishment and a health professional must ensure that sperm or ova that are in their possession or control and are intended for directed donation are segregated from sperm and ova that are not intended for directed donation.

Communication of Risk

Before distributing or making use

43 A health professional must meet the following requirements, in the context of directed donation, before making use of sperm or ova or distributing 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 his or her medical opinion, the use of the sperm or those ova would not pose a serious risk to human health and safety; and
• (b) create a document that states that he or she has informed the recipient of the risks that the use of the sperm or ova could pose to human health and safety and that he or she has obtained written consent from the recipient.

Identifying and Labelling

Identifying

Donor identification code

44 A primary establishment must ensure that a donor identification code is assigned to each donor.

Donation code

45 A primary establishment must ensure that a donation code is assigned to each donation of sperm and ova that indicates the date of the donation and links the donation to the donor.

Labelling

Establishment that labels

46 An establishment that labels an immediate container of sperm or ova must ensure that the donor identification code and the donation code appear on the label in a clear and indelible manner.

Primary establishment

47 A primary establishment must ensure that the immediate container of sperm or ova is already labelled in accordance with the requirements of section 46 and that it is accompanied by documentation that contains the following documents and information in English or French before distributing or making use of the sperm or ova :

• (a) the donor identification code and the donation code;
• (b) the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container;
• (c) in the case of exceptional access, a statement that indicates that the donation is for exceptional access only;
• (d) in the case of a directed donation, a statement that indicates that the donation is for directed donation only;
• (e) the name of the primary establishment, its registration number and contact information;
• (f) a copy of any summary document; and
• (g) instructions for the handling and storage of the sperm or ova.

Quality Management

Risk reduction

48 An establishment that conducts an activity must do so in such a way as to reduce the risks to human health and safety and the safety of sperm or ova by having appropriate quality management measures, including the taking of measures

• (a) to prevent contamination or cross-contamination;
• (b) to prevent the transmission of an infectious disease; and
• (c) to maintain the quality of the sperm or ova.

Quality Management System

Organizational structure

49 An establishment must have an organizational structure that sets out the responsibility of management for all activities that the establishment conducts.

Obligations

50 An establishment must establish and maintain a quality management system in respect of the activities it conducts that relate to human health and safety or the safety of the sperm or ova that is intended to prevent the following risks and must name an individual who has responsibility for that system:

• (a) the contamination or cross-contamination of sperm or ova; and
• (b) the transmission of an infectious disease.

Components of system

51 The quality management system must include the following components as well as standard operating procedures for all of those components and for all of the activities the establishment conducts:

• (a) a process control program for the activities it conducts that includes change control and validation systems;
• (b) a system that allows for process improvement that includes complaint monitoring and the implementation of corrective and preventative actions;
• (c) an internal audit system for quality management purposes;
• (d) a program for the initial and ongoing training of personnel and for evaluating their competency;
• (e) appropriate environmental control and monitoring systems for all facilities and areas in which activities are conducted;
• (f) a program for procuring and maintaining all critical equipment, supplies and services;
• (g) shipping standards;
• (h) a system for tracing sperm and ova;
• (i) a system that allows for the identification of errors, accidents and adverse reactions, for their investigation and reporting, for the implementation of corrective action as well as for the conduct of recalls; and
• (j) a document control and records management system.

Internal audit

52 An establishment must conduct an internal audit every two years of the activities that it conducts to verify that those activities comply with these Regulations and with its standard operating procedures, to be conducted by a person who is qualified to do so and who does not have direct responsibility for the activities being audited.

Standard Operating Procedures

Requirements

53 The standard operating procedures must meet the following requirements:

• (a) they are in a standardized format;
• (b) they are approved by the individual responsible for the quality management system;
• (c) they are easily accessible at each location where the relevant activities are conducted;
• (d) all changes to them are approved by the individual responsible for the quality management system before they are implemented; and
• (e) they are kept up-to-date.

Review of procedures

54 An establishment must review its standard operating procedures every two years or after either of the following events and every two years thereafter:

• (a) following any amendment to these Regulations; and
• (b) when a deficiency in the standard operating procedures is revealed as a result of an investigation into an error, accident or adverse reaction or as a result of an internal audit.

Personnel, Facilities, Equipment and Supplies

Personnel

55 In order to conduct its activities, an establishment must have sufficient personnel who are qualified by their education, training or experience to perform their respective tasks.

Facilities

56 The facilities in which an establishment conducts its activities must be constructed and maintained in a manner that allows for the following:

• (a) the carrying out of its activities;
• (b) the cleaning, maintaining and disinfecting of the facilities in a way that prevents contamination and cross-contamination; and
• (c) controlled access to all areas where its activities are conducted.

Environmental control system

57 An establishment must periodically inspect its environmental control system, which ensures the environmental conditions are appropriate to all areas in which its activities are conducted, in order to verify that the system functions properly and must take any necessary corrective action.

Equipment — general requirements

58 (1) An establishment that uses equipment to conduct its activities must clean and maintain the equipment and ensure that, whenever applicable, it is

• (a) qualified for its intended purpose;
• (b) calibrated;
• (c) disinfected or sterilized before each use; and
• (d) requalified or recalibrated, as appropriate, after any repair or change is made to it that results in a change to its specifications.

Storage equipment

(2) An establishment that uses equipment for the storage of sperm or ova must ensure that the equipment maintains appropriate environmental conditions.

Supplies

59 An establishment must ensure that the critical supplies that it uses are qualified or validated, as applicable, for their intended use and that they are stored under appropriate environmental conditions.

Containers

60 (1) An establishment that distributes, imports or makes use of sperm or ova must

• (a) verify the integrity of the immediate containers and the shipping containers as well as the accuracy and legibility of their labels; and
• (b) ensure that the documentation that accompanies the immediate containers contains the following information in English or French:
  • (i) the donor identification code and the donation code,
  • (ii) the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container,
  • (iii) in the case of exceptional access, a statement that indicates that the donation is for exceptional access only,
  • (iv) in the case of a directed donation, a statement that indicates that the donation is for directed donation only,
  • (v) the name of the primary establishment, its registration number and contact information ,
  • (vi) a copy of any summary document, and
  • (vii) instructions for the handling and storage of the sperm or ova.

Shipping

(2) An establishment that ships sperm or ova must

• (a) verify the integrity of the immediate containers and the shipping containers before shipping as well as the accuracy and legibility of their labels; and
• (b) use shipping containers that are capable of resisting damage, maintaining the safety of the sperm or ova and maintaining adequate environmental conditions during shipping.

Errors and Accidents

Error or accident by another establishment

61 (1) An establishment and a health professional that have or previously had sperm or ova in their possession and have reasonable grounds to believe that an error or accident by another establishment has occurred during the processing, distributing or importing of that sperm or those ova must immediately

• (a) determine the donor identification codes and donation codes of the implicated sperm or ova;
• (b) quarantine any implicated sperm or ova that are in their possession or control; and
• (c) notify the following:
  • (i) the establishment from which they received the implicated sperm or ova, and
  • (ii) in the case of an establishment, every establishment, health professional or recipient to which it distributed the implicated sperm or ova.

Contents of notice

(2) The notice must include the following information:

• (a) the donor identification code and the donation code associated with the implicated sperm or ova; and
• (b) the reason for the belief that an error or accident has occurred.

Action upon notice

(3) An establishment or health professional that is notified under subparagraph (1)(c)(ii) or under this subsection must immediately

• (a) quarantine all implicated sperm or ova in its possession or control; and
• (b) in the case of an establishment, notify to the same effect every establishment, health professional and recipient to which it distributed the implicated sperm or ova.

Written notice

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

Establishment or health professional — own error or accident

62 (1) An establishment and a health professional that have or previously had sperm or ova in their possession and have reasonable grounds to believe that an error or accident has occurred during the processing, distributing or importing of that sperm or those ova that they conducted must immediately

• (a) determine the donor identification codes and the donation codes of the implicated sperm or ova;
• (b) quarantine any implicated sperm or ova that are in their possession and control; and
• (c) initiate an investigation into the suspected error or accident.

Notice of investigation

(2) An establishment that initiates an investigation must immediately notify every establishment, health professional or recipient to which it distributed implicated sperm or ova and must include the following information in the notice:

• (a) the donor identification codes and donation codes of all implicated sperm or ova; and
• (b) 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.

Action upon notice

(3) An establishment or health professional that is notified under subsection (2) or under this subsection must immediately

• (a) quarantine all implicated sperm or ova in its possession or control; and
• (b) in the case of an establishment, notify to the same effect every establishment, health professional or recipient to which it distributed implicated sperm or ova.

Written notice

(4) If an establishment or a health professional gives a notice verbally under this section, the notice must be confirmed in writing within 24 hours after it is given.

Requirement to cooperate

63 An establishment and a health professional must, on request, provide to any establishment or health professional that is conducting an investigation any relevant documents or information in its possession in respect of implicated sperm or ova.

Results of investigation

64 (1) An establishment that conducts an investigation must notify in writing every establishment, health professional or recipient to which it distributed implicated sperm or ova of the results of the investigation and of any action that is required to be taken.

Action on receipt of notice

(2) An establishment that receives a notice under subsection (1) or a copy of such a notice under this subsection must send a copy of the notice to every establishment, health professional or recipient to which it distributed implicated sperm or ova.

Release from quarantine

65 An establishment or health professional that quarantines implicated sperm or ova must continue to do so until the results of the investigation reveal that the safety of the implicated sperm or ova is not compromised.

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 for exceptional access to that sperm or those ova from a health professional and if one of the following conditions is met:

• (a) the recipient has previously been exposed to sperm from that donor that was retested at the same time as the sperm that is requested;
• (b) the recipient has previously been exposed to ova from that donor that was obtained on the same day as the ova that are requested;
• (c) 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 .

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 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.

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.

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 his or her 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 he or she has informed the recipient of the risks that the use of the sperm or ova could pose to human health and safety and that he or she has obtained written consent from the recipient.

Preliminary and interim reports

67 The establishment or health professional that conducts an investigation into a suspected error or accident that could lead to an adverse reaction must send the following reports to the Minister, in the form established by the Minister, at the following times:

• (a) within 72 hours after the start of the investigation, a preliminary report that includes a detailed description of the suspected error or accident and any relevant information that is available at that time; and
• (b) within 15 days after the start of the investigation and every 15 days after that until the final report is made, an interim report that contains
  • (i) any new information with respect to the suspected error or accident,
  • (ii) the progress of the investigation, and
  • (iii) any measures taken during those 15 days to mitigate further risk.

Final report

68 An establishment or health professional that conducts an investigation into a suspected error or accident that could lead to an adverse reaction must send, within 72 hours of completing the investigation, a detailed final report to the Minister, in the form established by the Minister, that contains the following information:

• (a) the results of the investigation;
• (b) any corrective action taken; and
• (c) details concerning the disposition of the implicated sperm or ova.

Adverse Reactions

Action to be taken

69 (1) An establishment and a health professional that have reasonable grounds to believe that an adverse reaction has occurred must immediately

• (a) determine the donor identification codes and donation codes of any implicated sperm or ova in their possession;
• (b) quarantine any of the implicated sperm or ova in their possession and control; and
• (c) notify the following:
  • (i) the primary establishment that processed the implicated sperm or ova, and
  • (ii) if the sperm or ova were imported, the establishment that imported the sperm or ova.

Contents of notice

(2) The notice must include the following information:

• (a) the donor identification code and the donation code of the implicated sperm or ova;
• (b) a description of the adverse reaction;
• (c) the name of any suspected infectious disease or disease agent, if known; and
• (d) an explanation of how the safety of the implicated sperm or ova might have been compromised, if known.

Action upon notice

(3) An establishment that is notified under subsection (1) or under this subsection must immediately

• (a) quarantine any of the implicated sperm or ova that are in its possession or control; and
• (b) notify to the same effect every establishment, health professional and recipient to which it distributed the implicated sperm or ova.

Written notice

(4) If an establishment or a health professional gives a notice verbally under this section, the notice must be confirmed in writing within 24 hours after it is given.

Investigation

70 (1) On receipt of a notice, a primary establishment must initiate an investigation immediately into the adverse reaction.

Requirement to cooperate

(2) An establishment and a health professional must, on request, provide to any primary establishment that is conducting an investigation any relevant documents or information in its possession in respect of implicated sperm or ova.

Results of investigation

71 (1) A primary establishment that conducts an investigation must notify in writing every establishment, health professional or recipient to which it distributed implicated sperm or ova of the results of the investigation and of any action that is required to be taken.

Action on receipt of notice

(2) An establishment that receives a notice under subsection (1) or a copy of such notice under this subsection must send a copy of the notice to every establishment, health professional or recipient to which it distributed implicated sperm or ova.

Release from quarantine

72 An establishment or health professional that quarantines implicated sperm or ova must continue to do so until the results of the investigation reveal that the safety of the implicated sperm or ova is not compromised.

Release from quarantine — exceptional access

73 (1) Despite section 72, an establishment and a health professional may release sperm or ova from quarantine if they receive a request 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 from that donor that was retested at the same time as the sperm that is requested;
• (b) the recipient has previously been exposed to ova from that donor that were obtained on the same day as the ova that are requested;
• (c) 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 .

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 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;
• (d) a description of the adverse reaction;
• (e) the name of any suspected infectious disease or disease agent, if known; and
• (f) an explanation of how the safety of the implicated sperm or ova might have been compromised, if known.

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.

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 his or her 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 he or she has informed the recipient of the risks that the use of the sperm or ova could pose to human health and safety and that he or she has obtained written consent from the recipient.

Preliminary and interim reports

74 A primary establishment that is conducting an investigation into an adverse reaction must send the following reports to the Minister, in the form established by the Minister, at the following times:

• (a) within 72 hours after the start of the investigation, a preliminary report that includes a detailed description of the adverse reaction and any relevant information that is available at that time; and
• (b) within 15 days after the start of the investigation and every 15 days after that until the final report is made, an interim report that contains the following information,
  • (i) any new information with respect to the adverse reaction,
  • (ii) the progress of the investigation, and
  • (iii) any measures taken during those 15 days to mitigate further risk.

Final report

75 A primary establishment must send, within 72 hours of completing the investigation, a detailed final report to the Minister, in the form established by the Minister, that contains the following information:

• (a) the results of the investigation;
• (b) any corrective action taken; and
• (c) details concerning the disposition of the implicated sperm or ova.

Records

General

76 (1) An establishment and a health professional must keep records that contain all the documents and information required under these Regulations and all other records that demonstrate that they meet the requirements of these Regulations.

Donor identification codes and donation codes

(2) An establishment and a health professional must ensure that the donor identification code and the donation code are components of all of their records that relate to the processing, distribution, importation or making use of sperm or ova.

Retention period — general

77 (1) An establishment and a health professional must keep records for 10 years after their creation unless otherwise specified in these Regulations.

Retention period — employees

(2) An establishment must keep records containing records of the qualifications, training and competency of its employees for 10 years after the day on which an individual ceases to be an employee of the establishment.

Retention period — standard operating procedures

(3) An establishment must keep a copy of every version of its standard operating procedures for 10 years after the day on which they are superseded by a new version.

Processing

78 (1) A primary establishment must keep records that contain the following documents and information with respect to the sperm or ova it processes:

• (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova;
• (b) the number of immediate containers on which the same donation code appears;
• (c) the type of donation, whether sperm or ova;
• (d) the date of the donation;
• (e) any documents and information with respect to the suitability of the donor;
• (f) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova; and
• (g) any information with respect to the disposition of the sperm or ova.

Establishment to cooperate

(2) An establishment that processes sperm or ova on behalf of a primary establishment must provide to the primary establishment all of the documents and information that it possesses to update the primary establishment's records.

Distribution and importation

79 An establishment that distributes or imports sperm or ova and a health professional who distributes sperm to a recipient for their personal use must keep records that contain the following documents and information with respect to that sperm or those ova:

• (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova;
• (b) the number of immediate containers on which the same donation code appears;
• (c) the contact information for the establishment from which the establishment or health professional received the sperm or ova, if applicable;
• (d) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova;
• (e) the contact information for each establishment, health professional or recipient to which the establishment or health professional distributes the sperm or ova, if applicable; and
• (f) any information with respect to the disposition of the sperm or ova.

Making use

80 (1) An establishment and a health professional must keep records that contain the following documents and information with respect to the sperm or ova it uses:

• (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova;
• (b) the number of immediate containers on which the same donation code appears;
• (c) the contact information and registration number of the primary establishment that processed the sperm or ova;
• (d) if applicable, the contact information for the establishment from which the establishment or health professional received the sperm or ova , if they were not received from a primary establishment;
• (e) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova;
• (f) any information that allows for the identification of the recipient; and
• (g) any information with respect to the disposition of the sperm or ova.

Establishment to cooperate

(2) An establishment must provide to the establishment and health professional all of the documents and information that it possesses to update the establishment and health professional's records.

Retention period — processing, distribution, importation and making use

81 An establishment and a health professional must keep records in respect of each immediate container of sperm or ova for a period of 10 years after the day on which they distribute, make use of or effect the disposition of the sperm or ova.

Investigation

82 (1) An establishment or health professional that has conducted or received a notice of an investigation respecting an accident, error or adverse reaction must keep records that contain

• (a) any documents and information with respect to the investigation;
• (b) any notices that were received and copies of those that were sent and a list of all the establishments, health professionals or recipients to which they were sent; and
• (c) a copy of any reports sent to the Minister.

Retention period

(2) An establishment and a health professional must keep records for a period of 10 years after the date of the last recording in that record.

Record qualities

83 (1) Records containing documents and information must be complete and kept in a manner that allows them to be audited at any time.

Information qualities

(2) The information must be accurate, legible and indelible.

Storage of records

84 An establishment and a health professional must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.

Transitional Provisions

Primary establishment not registered

85 (1) A primary establishment that, before the day on which these Regulations come into force, processes sperm or ova, may continue to do so, despite section 4, without a registration if it files an application for registration under section 5 within three months after that day.

Duration

(2) Subsection (1) applies until the determination of the application made under section 5.

Distribution or importation before coming into force of these Regulations — notice

86 An establishment that, before the day on which these Regulations come into force, distributes or imports sperm or ova may continue to do so, despite section 18, if it sends a notice to the Minister that meets the requirements of that section within three months after that day.

Distribution or importation — requirements

87 (1) An establishment that, on or before the day these Regulations come into force, distributes or imports sperm or ova must ensure that

• (a) the sperm or ova were processed in accordance with these Regulations by a primary establishment; and
• (b) the primary establishment has filed an application for registration under section 5 within three months after the day on which these Regulations come into force.
  

Duration

(2) Subsection (1) applies until the determination of the application made under section 5.

Sperm obtained before these Regulations come into force

88 (1) This section applies to sperm that is obtained before the day on which these Regulations come into force and that may be distributed, imported and used — despite the requirements set out in sections 22 to 43 – only if

• (a) the sperm is processed, within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations, in accordance with those Regulations; or
• (b) the sperm is the subject of a special access authorization under section 20 of those Regulations.
  

Special access authorization

(2) Despite subsection (1), sperm that is the subject of a special access authorization may only be distributed and used for the purpose for which the authorization is granted.

Immediate container

(3) Before distributing or making use of the sperm, an establishment and a health professional must ensure that the identification code, within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations, appears in a clear and indelible manner on the label of the immediate container.

Documentation

(4) Before distributing or making use of the sperm, an establishment and a health professional must ensure that the immediate container of sperm is accompanied by documentation that contains the following information in English or French:

• (a) the donation code;
• (b) the name and business address of the processor within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations;
• (c) the date of the donation, the tests performed in respect of the donor, the dates and results of the tests and, if necessary, an interpretation of the results; and
• (d) a copy of the special access authorization, if any.

Records

89 An establishment and a health professional must keep records of all documents and information as required under the Processing and Distribution of Semen for Assisted Conception Regulations, in respect of each immediate container of sperm, unless otherwise required by these Regulations, for a period of 10 years after the day on which they distribute, make use of or effect the disposition of the sperm.

Consequential Amendment to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

90 Paragraph 3(1)(j) of the Safety of Human Cells, Tissues and Organs for Transplantation Regulations ^{footnote 20} is repealed.

Repeal

91 The Processing and Distribution of Semen for Assisted Conception Regulations ^{footnote 21} are repealed.

Coming into Force

Six months after publication

92 (1) Subject to subsection (2), these Regulations come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.

One year after publication

(2) Paragraphs 11(2)(b), 18(1)(f), 47(e) and 80(1)(c) as they apply to registration numbers and section 3 come into force on the first anniversary of the day on which these Regulations are published in the Canada Gazette, Part II.