Toward a strengthened Assisted Human Reproduction Act
A Consultation with Canadians on Key Policy Proposals
In October 2016, recognizing the need to strengthen the regulatory framework governing assisted human reproduction in Canada, Health Canada announced its intention to bring into force the dormant sections of the Assisted Human Reproduction Act and to develop the necessary supporting regulations.
This consultation document provides an overview of the key policy proposals that will help inform the development of regulations to support bringing into force Section 10, Section 12 and Sections 45-58 of the Act. Specifically, the policy proposals describe the Department’s position on the following:
Section 10: Safety of Donor Sperm and Ova
- Scope and application
- Regulated parties and their regulatory obligations
- Processing requirements, including donor suitability assessment
- Record-keeping and traceability
Section 12: Reimbursement
- Expenditures that may be reimbursed
- Process for reimbursement
- Creation and maintenance of records
Sections 45-58: Administration and Enforcement
- Scope of the administration and enforcement framework
- Role of inspectors designated under the Act
The purpose of the document is to provide Canadians with an opportunity to review the policy proposals and to provide feedback prior to the Department finalizing policy decisions and developing the regulations. In addition to requesting stakeholders’ general feedback on the policy proposals, the Department is also seeking input on specific questions, which are included throughout the document.
Table of Contents
- 1. Introduction
- 2. Feedback Information Request
- 3. Background
- 4. Policy Proposals for Consideration
- 4.1. Section 10 - Product Safety
- 4.2. Section 12 Reimbursement
- 4.3. Section 45 to 58 – Administration and enforcement
- 5. How to Submit Feedback
- 6. Appendix
Health Canada is committed to promoting transparency and stakeholder engagement during the regulatory development process. This includes providing Canadians with opportunities to provide meaningful feedback on important policy proposals.
In October 2016, recognizing the need to strengthen the regulatory framework governing assisted human reproduction (AHR) in Canada, the Minister of Health announced Health Canada’s intention to bring into force the dormant sections of the Assisted Human Reproduction Act (AHR Act) and to develop the necessary supporting regulations.
This work includes drafting regulations aimed at reducing the risks to human health and safety arising from the use of assisted human reproductive technologies; drafting regulations regarding reimbursement of expenses incurred by donors and surrogates, and drafting the regulations necessary for the purpose of administering and enforcing the Act.
This document provides an overview of Health Canada’s key policy proposals that will help inform the development of regulations to support bringing into force Section 10, Section 12 and Section 45-58 of the Act. The purpose of this paper is to serve as a basis for early feedback and engagement with Canadians prior to the Department finalizing policy decisions and developing draft regulations. Canadians will have another opportunity to provide feedback when the draft regulations are published in Canada Gazette, Part I.
2. Feedback Information Request
Health Canada wants to hear directly from Canadians. This includes feedback from those who make use of and those who are born of AHR, those who are part of the AHR sector, including health professionals, industry members, fertility lawyers, as well as academics, researchers and all others who have an interest in these policy proposals.
All feedback provided on the policy proposals outlined in this consultation document will be considered prior to the development of regulations for Section 10, Section 12 and Sections 45 to 58 of the AHR Act.
For information on how to submit feedback, please refer to section 5.0 of this consultation document.
3.1. History of the Assisted Human Reproduction Act
The AHR Act received royal assent on March 29, 2004. The Act was based on recommendations made by the 1993 Royal Commission on New Reproductive Technologies, which had the mandate to examine the ethical, legal, social and economic implications of reproductive technologies and their impact on Canadian society, and in particular on women, children and families.
The Act introduced a system of licensing, monitoring, inspection and enforcement designed to protect and promote the health, safety, dignity and rights of Canadians who use or are born of AHR technology. The Act was a comprehensive regulatory framework which identified prohibited activities and activities that were prohibited unless they were licensed, and it introduced new compliance and enforcement powers. It also created Assisted Human Reproduction Canada (AHRC), the federal Agency responsible for a wide range of activities related to AHR, including issuing and reviewing licences under the AHR Act, compliance and enforcement, and collecting, analyzing and managing health reporting information.
The legislation is written in such a way that many sections of the Act require the development and publication of regulations in order to come into force. Health Canada has been responsible for leading this regulatory work and in June 2007, the first of these sections was brought into force with the publication of the Section 8 Consent Regulations. These regulations set out requirements for how consent is provided or withdrawn with respect to the use of someone's reproductive material or in vitro embryos including the purposes for which consent to use can be provided.
In June 2008, before further regulatory work could be completed, the Quebec Court of Appeal ruled that significant portions of the AHR Act were unconstitutional in response to a 2004 filing by the provincial government. The Government of Canada filed an appeal to the Supreme Court of Canada (SCC) in August 2008 regarding the constitutionality of the challenged provisions. The SCC rendered its opinion in December 2010, finding almost all challenged sections unconstitutional, notably provisions relating to the Act’s licensing framework in areas connected to the provinces’ exclusive jurisdiction over hospitals and the practice of medicine, as well as those relating to the collection of health reporting information the regulation of AHR activities and related research.
In response to the SCC opinion, legislation was introduced in 2012 to repeal the sections of the AHR Act deemed unconstitutional for infringing on provincial jurisdiction as well as the sections establishing and providing the mandate of AHRC, which closed in September 2012. With the closure of the AHRC, Health Canada took over responsibility for all remaining federal functions related to the Act, such as compliance and enforcement, and outreach. As a result of the legal environment surrounding the AHR Act, the drafting of regulations for the remaining sections of the Act was put on hold.
3.2. AHR in Canada Today
Today, an increasing number of Canadians are turning to AHR technologies to grow or build their families. A 2012 Canadian studyFootnote 1 found that infertility is on the rise in Canada, with roughly 16% of heterosexual couples experiencing infertility. In addition to rising infertility, the trend of delaying marriage and parenthood, scientific advances in cryopreserving ova, and the increasing use of AHR by LGBTQ2 couples and single parents to build a family are all contributing to an increase in the use of AHR technologies.
The growing use of reproductive technologies by Canadians to help build their families underscores the need to strengthen the AHR Act. While the approach to regulating AHR varies from country to country, Health Canada has considered international best practices and the need for regulatory alignment when developing the proposed policies set out in this document. (See Appendix A: International Comparison of AHR Regulatory Oversight)
3.2.1 Federal Regulatory Oversight
Although the scope of the AHR Act was significantly reduced in 2012 and some of the remaining sections have not yet been brought into force, there are many important sections of the Act that are currently administered and enforced by Health Canada, as summarized generally below:
Sections 1-4: Principles and Application
Sections 1-4 establish the application of the Act and define some of the terms contained within the legislation. Of particular importance is Section 2, which sets out key principles that underpin the remainder of the Act.
Section 5: Prohibited Scientific and Research Procedures
Section 5 prohibits certain types of scientific research and clinical procedures that are deemed unacceptable, including: human cloning, the creation of an embryo for non-reproductive purposes, maintaining an embryo outside the human body beyond the fourteenth day, sex selection for non-medical reasons, altering the genome in a way that could be transmitted to descendants, and creating a chimera or a hybrid.
Sections 6 & 7: Non-Commercialization Prohibitions
One of the principles set out in Section 2 of the Act recognizes that trade in the reproductive capabilities of women and men, and the exploitation of children, women and men for commercial ends raise health and ethical concerns that justify their prohibition. As a result, Sections 6 and 7 prohibit payment for surrogacy and the purchase of sperm and ova from a donor or a person acting on behalf of a donor, respectively.
Section 8: Consent
Section 8 prohibits the use of reproductive material unless consent is obtained from the donor, in accordance with the Consent to Use Regulations.
Section 9: Minimum Age for Gamete Donors
Section 9 prohibits any person from obtaining sperm or ova from a donor under 18 years of age, or using any sperm or ova so obtained, except for the purpose of preserving it for the minor's own future reproductive use (e.g. in the case of a minor undergoing treatment that may affect his or her reproductive capabilities, such as cancer therapy).
Remaining Provisions not yet in Force
The majority of the remaining sections of the AHR Act as introduced in 2004 were repealed as a result of the SCC decision in 2012. This proposal seeks to lay the policy ground for bringing Sections 10, 12 and 45-58 into force as part of the current regulatory work to strengthen the Act.
Regulation of Sperm
Regulations for sperm were first introduced in Canada in 1996 under the Food and Drugs Act, in response to an urgent health and safety risk, namely the transmission of HIV via semen. In 2000, the Health Canada Directive: Technical Requirements for Therapeutic Donor Insemination was published, which updated the requirements for donor suitability assessment, including donor screening and testing, to reflect scientific advances and clarify some questions of regulatory oversight.
3.2.2. Regulatory Gaps
Scientific advances since the AHR Act was first introduced have left health and safety gaps with respect to donor sperm and ova used for the purpose of AHR that must be addressed. For instance, there is a need to modernize the regulatory requirements for the safety of donor sperm, and move them from the Food and Drugs Act to the AHR Act. Furthermore, to date, no regulatory requirements for the safety of donor ova have been introduced in Canada.
Similarly, the knowledge gained through scientific advances in human genetics, combined with new possibilities for mitigating the risk of transmitting genetic diseases to donor-conceived offspring, allows for regulatory improvements to the safety of donor sperm and ova previously never envisioned. Furthermore, other scientific advances have led to previously unforeseen regulatory challenges, such as the application of CRISPR/Cas-9 technology to germline editing research and mitochondrial replacement therapy.
Although the scope of this project does not include revisiting the prohibitions currently in force, including those that prohibit the purchase of sperm and ova from a donor or persons acting on behalf of a donor, or payment for surrogacy arrangements, there is a clear need for providing Canadians with more clarity on the types of expenses that can be reimbursed and outlining a process for doing so.
Did you Know?
The safety of donor sperm is currently regulated by the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations) made under the Food and Drugs Act. They will be repealed once section 10 of the AHR Act is brought into force.
3.2.3. The Canadian Standards Association
In 2000, before the AHR Act came into force, Health Canada contracted the Canadian Standards Association (CSA) to develop a national standard on tissues for assisted reproduction.
The CSA is an independent, not-for profit member based association, accredited by the Standards Council of Canada (an organization that co-ordinates Canada’s National Standards System). The CSA maintains its accreditation by developing consensus standards, where all members have an equal voice. The CSA Reproductive Tissues Standard sets out minimum standards and best practices for organizations and individuals involved in all aspects of assisted reproduction. Although the standard does not have the force of law and some of its scope extends beyond federal jurisdiction, its key objective is to enhance the safety and effectiveness of AHR technologies in order to protect individuals who use or who are conceived through assisted reproduction and to guide health care personnel.
Although Health Canada has membership on the CSA Technical Subcommittee responsible for maintaining and updating the standard, a consensus-based process is implemented by the subcommittee to determine its content. The Department has leveraged some of the work done by the Technical Subcommittee in developing the policy proposals contained within this document.
Did you Know?
The CSA, a non-governmental organization, has responsibility for maintaining their Reproductive Tissues Standard. The CSA Technical Subcommittee is in the process of developing updated evidence-based infectious disease screening criteria for sperm and ova donors.
3.3 Intention to Strengthen the AHR Act
On October 1, 2016 Health Canada announced its intention to update and strengthen the AHR Act.
A Notice of Intent (NOI) published in the Canada Gazette outlined the Department’s plans to draft regulations in order to bring into force key sections of the Act. Specifically, Health Canada announced plans to:
- Draft regulations aimed at reducing the risks to human health and safety arising from the use of donor sperm and ova for the purpose of AHR, including the risk of the transmission of disease, and bring section 10 of the AHR Act into force;
- Draft regulations regarding reimbursement of expenses incurred by donors and surrogates and bring section 12 of the AHR Act into force; and,
- Draft supporting regulations, as required, to bring into force sections 45 to 58 and designate inspectors for the purpose of administering and enforcing the Act and its regulations.
The Department invited the public to submit their feedback on the proposed initiative. A 60 day consultation period took place with various stakeholders participating, including individuals who use AHR procedures, fertility clinics, researchers, academics, gamete banks, fertility lawyers, and various association groups (e.g. medical associations, LGBTQ2 groups, fertility awareness groups).
The feedback received from stakeholders has helped to inform the important policy work undertaken by Health Canada that will underpin the regulatory development process.
3.4. Stakeholder Feedback
In general, Canadians who commented on the NOI are supportive of the Department’s intention to strengthen the AHR Act, some citing the continued importance of the legislation and the fact that action is overdue. Some stakeholders have also expressed the need to address specific areas currently lacking regulatory oversight, including:
The need for:
- Evidence based screening and testing requirements for sperm and ova donors
- Regulatory requirements for processing, handling and quarantining of donated ova
These issues will be discussed in section 10 policy proposals (See section 4.1 of this document)
The need for:
- Clarity on type and nature of expenses incurred by donors and surrogates that may be reimbursed
- A reimbursement process that is not overly burdensome
These issues will be discussed in section 12 policy proposals (See section 4.2 of this document)
Administration and Enforcement
The need for:
- A comprehensive compliance system that has oversight over importers, processors and distributors
- Transparent auditing and inspection systems and effective complaint handling
These issues will be discussed in sections 10 and 45-58 policy proposals (See sections 4.1 and 4.3 of this document)
Out of Scope of Current Regulatory Project
Many other comments beyond the narrow scope of the current regulatory project were received, including the need to:
- Review the procedures prohibited by section 5 of the AHR Act (e.g. germline editing) in light of scientific advances
- Revisit the policy underpinning sections 6 and 7 of the Act, which prohibit payment for surrogacy and the purchase of sperm and ova
- Reconsider the penalties associated with medical and scientific activities
While these issues will not be addressed during the current regulatory project, they will be considered in the future when amendments to the AHR Act may be contemplated.
4. Policy Proposals for Consideration
In order to develop the regulations required to bring into force sections 10, 12 and 45 to 58 of the AHR Act, key policy issues related to those sections had to be explored. The purpose of this part of the consultation paper is to outline the proposed policy foundation on which Health Canada proposes to build the regulations. Questions have been identified throughout the following sections to help guide the consultation process.
4.1 Section 10 - Product Safety
Section 10 of the AHR Act was introduced in 2012, when the Act was amended to repeal the sections that had been deemed unconstitutional by the SCC. The purpose of section 10 is to reduce the risks to human health and safety arising from the use of sperm or ova for the purpose of AHR, including the risk of the transmission of disease. Section 10 achieves this purpose by prohibiting the distribution, use or importation of donor sperm or ova unless it complies with the section 10 regulations.
4.1.2. Principles and Objectives
The objective of the product safety regulatory framework under the AHR Act is to protect the health and safety of Canadians who use AHR to help build their families, as well as to protect those who are born of these technologies.
Policy work to develop the section 10 regulations has been guided by the following principles:
- The role of Health Canada is to reduce the risks to human health associated with the use of donor sperm and ova for third party use;
- Individuals have the right to make an informed decision to accept certain risks in using AHR technology to build their families;
- The role of the treating physician in assessing these risks and counselling their patients is a critical one in the safe application of AHR technology; and,
- The unique and personal nature of third party reproduction gives rise to circumstances that should be taken into consideration.
There is a risk of disease transmission associated with the use of third party sperm or ova for the purpose of AHR, including the use of third party sperm in in vitro fertilization (IVF). This includes the risk of infectious disease transmission from the donor to the recipient, as well as to the child born of AHR technologies, as well as the risk of genetic disease transmission from the donor to the child.
As such, Health Canada proposes that section 10 regulations include measures to reduce the risks associated with transmission of both infectious and genetic disease, from the sperm or ovum donor to the recipient, and/or to the children born through AHR.
Health Canada recognizes the right of individuals to make an informed decision to accept certain risks in using AHR technologies to build their families and the important role of the treating physician in assessing those risks and counselling their patients. In keeping with these principles and in response to years of stakeholder feedback on this issue, the Department is proposing to introduce a more flexible regulatory framework that is responsive to the needs of individuals who use AHR, while still protecting their health and safety. In particular, Health Canada is proposing to introduce changes to make it easier for Canadians who know their donor to proceed with building their families. This section describes the proposed regulatory framework.
Application and Authorities
The proposed section 10 regulations will apply to donor sperm and ova intended for use in AHR by a recipient who is not the spouse, common-law partner or sexual partner of the donor, as well as to ova intended for the donor’s use as a surrogate. This includes the use of donor sperm in IVF.
The AHR Act provides the authority to make regulations that exempt persons from section 10, conditionally or unconditionally, in the circumstances provided for in regulations. In keeping with the principles described in the previous section, Health Canada proposes the following exemptions:
Unknown future use: Sperm and ova will be exempt from section 10 where the future use of the sperm and ova is unknown at the time of cryopreservation. This exemption is meant to include cases such as sperm or ova cryopreserved prior to a patient undergoing a medical treatment or procedure that may affect his/her fertility (e.g. cancer treatment) and where the use of the cryopreserved gamete has not yet been determined (e.g. patient does not have a spouse, common-law partner or sexual partner, or it is unclear if the services of a surrogate would be required, at the time of sperm or ova cryopreservation).
Note: Where sperm or ova that was originally cryopreserved for unknown future use is subsequently intended for third party use, and where the sperm or ova was not processed in accordance with the section 10 regulations, the use may be permitted under Exceptional Distribution, as described below.
Ova processed prior to section 10 coming into force: Ova processed before section 10 comes into force will not be subject to the requirements of section 10 regulations.
Sperm processed prior to section 10 coming into force: Sperm processed before section 10 comes into force will not be subject to the requirements of the section 10 regulations, provided that the sperm has been processed in accordance with the current Semen Regulations.
Directed Donation: All donors must be screened and tested in accordance with section 10; however, if a recipient has chosen someone they know as their donor, the recipient can choose to move ahead with the donation even in the event that their donor does not meet the screening and testing criteria. This will give Canadians more flexibility in choosing their donor and will make it easier to proceed with building their families.
For those who have chosen someone who they know as their donor, the donated sperm or ova will be exempt from the section 10 regulations provided certain conditions are met, including:
- The sperm or ova have been processed in accordance with section 10 regulations; and,
- The donor’s suitability has been conducted in accordance with the section 10 regulations.
Introducing these conditions will help the treating physician to assess the risks associated with using the directed donation, and to inform the recipient of those risks. The physician’s assessment, combined with their authorization, will allow the recipient to make an informed decision with respect to the use of the sperm or ova in directed donation.
Exceptional Distribution: The use of cryopreserved donor sperm and ova that have not been processed in accordance with the AHR Act will be permitted under some exceptional circumstances, including:
- Sperm that is not compliant with section 10 regulations may be permitted under exceptional distribution where the recipient has already been exposed to the donor sperm (e.g. women or couples who have already had a child through AHR and wish to have another child using non-compliant semen from the same donor to ensure their children will be genetic siblings).
- Sperm processed before section 10 regulations come into force, and not deemed compliant with the Semen Regulations, may be permitted under exceptional distribution where the recipient has already been exposed to the donor sperm (e.g. to create genetic siblings), or for the use of a specific third party recipient who knows the donor and is known by the donor.
- Sperm or ova exempt from the regulatory requirements of section 10 (i.e., originally intended for the use by the spouse, common-law partner or sexual partner of the donor and no longer needed for family building purposes, or cryopreserved for unknown future use) may be permitted for use of a specific third party recipient who knows the donor and is known by the donor.
QUESTION FOR STAKEHOLDERS
Q1: Please explain any other circumstances that should be exempt, conditionally or unconditionally, from section 10 of the AHR Act.
Exceptional distribution of donor sperm and ova will only be permitted provided:
- The donor sperm or ova has already been obtained and obtaining another sample of sperm or ova that is processed in accordance with section 10 of the AHR Act is not possible or would pose a risk to the health of the donor;
- Reproductive needs of the recipient cannot be met using a sperm/ovum that is processed in accordance with section 10 of the AHR Act (e.g. women or couples who have already had a child through AHR and wish to have another child using non-compliant semen from the same donor to ensure their children will be genetic siblings); and,
- The use of Exceptional Distribution is not intended to circumvent the regulations.
Other conditions for exceptional distribution will also need to be met, such as a completed donor suitability assessment, the purpose of which will be to help the treating physician and the patient make informed decisions regarding the risks involved in using the gamete.
Health Canada proposes that additional labelling requirements also be introduced to mitigate risks associated with sperm and ova not processed in accordance with the regulations and where the donor suitability requirements have not been met.
Note: Exceptional Distribution is intended to replace the Donor Semen Special Access Programme (DSSAP), which will no longer exist once section 10 of the AHR Act is brought into force.
4.1.5. Requirements for Persons who Process, Import, Distribute, or Make Use
Health Canada is proposing to oversee supply chain compliance and integrity for donor sperm and ova through a registration and notification scheme to:
- Support high standards of quality and safety for gametes intended for AHR; and,
- Support protection of human health via product traceability.
The proposed regulations would complement and be supported by existing provincial and territorial laws, particularly as they pertain to the practice of medicine in Canada.
Regulated Parties and Activities
Processors: Health Canada is proposing to define processors as persons responsible for the processing activities with respect to donor sperm and ova for use in AHR. A processor would also be responsible for determining whether the sperm and ova are safe and would be required to apply for a registration number with Health Canada as per the registration requirements detailed below. Toward this end, Health Canada is proposing that only the processor who is ultimately responsible for the safety and quality of the donor sperm and ova will be required to register and they will be responsible for ensuring both their compliance with the AHR Act and its regulations, as well as the compliance of any third party contractors that they use for any aspect of processing donor sperm or ova for AHR.
Processing activities include obtaining, preparing, preserving, quarantining, identifying, labelling and storing, and assessing the quality of donor sperm and ova for use in AHR. It also includes the testing and screening of donors to assess their suitability.
This proposed definition encompasses both foreign and domestic processors and includes persons processing both directed and anonymous donations.
Importers: Heath Canada is proposing to define importers as persons in Canada who import donor sperm and ova from a foreign country for the purpose of distribution for use in AHR, including storing donor sperm and ova for the purpose of distribution. Importers would be required to notify Health Canada, as per the notification requirements outlined below, and would be required to only import donor sperm and ova from processors that are registered with Health Canada. Unlike the current approach under the Semen Regulations, a qualified medical professional who directly imports sperm or ova solely for use in AHR would be a user, not an importer.
Distributors: Health Canada is proposing to define distributors as persons in Canada who distribute donor sperm and ova for use in AHR, including storing donor sperm and ova for the purpose of distribution. Distributors would be required to notify Health Canada as per the notification requirements, outlined below, and would be required to obtain donor sperm and ova from processors that are registered with Health Canada. Unlike the current approach under the Semen Regulations, a qualified medical professional who solely makes use of donor sperm or ova in the performance of AHR would be a user, not a distributer.
Users: Health Canada is proposing to define users as persons who make use of donor sperm or ova in the performance of AHR in a clinical setting, including storing donor sperm and ova for the purpose of making use. For example, this definition would include persons who:
- Import cryopreserved donor sperm and ova that is being stored for use in a fertility clinic in a foreign country to a fertility clinic in Canada;
- Make use of donor sperm and ova, such as qualified medical professionals who perform assisted human reproduction procedures;
- Directly import donor sperm and ova for use in AHR, such as a qualified medical professional who imports sperm or ova solely for use in AHR on a single patient; and,
- Store donor sperm and ova solely for the purpose of making use.
Note: Health Canada is proposing to not consider persons who use donor sperm or ova outside of a clinical setting (e.g. at-home insemination) as users.
Under this proposed framework, users would not be required to notify or register with Health Canada, but will be required to obtain donor sperm and ova from only registered processors.
Furthermore, Health Canada proposes that all users of donor sperm or ova will be required to maintain records that identify the patient on whom the assisted reproduction was performed.
Finally, for greater clarity, if a user of donor sperm or ova engages in a regulated activity for which notification or registration is required, Health Canada is proposing that they will not be exempt from the regulatory requirements of that activity.
Health Canada is proposing that the names of all registered processors and Canadian importers and distributors that have notified Health Canada will be posted on the Health Canada web site and used as a reference tool for users of donor sperm and ova and interested stakeholders.
Health Canada is also proposing to make information about non-compliant processors, importers, and distributors public. This will support a more informed consumer so that Canadians make more informed choices about their health. Regulatory transparency will also strengthen the safety, security, and integrity of the supply chain by:
- Supporting a culture of safety and quality within the reproductive health sector;
- Fostering public participation and stakeholder engagement with respect to scrutiny and accountability of regulated parties; and,
- Enhancing public confidence in the oversight of donor sperm and ova for assisted human reproduction.
Processors perform high risk activities and are responsible for ensuring the quality and safety of donor sperm and ova to which Canadians have access. As such, Health Canada is proposing that all processors will be required to apply for a registration number with Health Canada through an application form. It is being proposed that applicants for a registration number will be required to submit the following information:
- Details about the processor’s business information, civic address and contact details;
- Information about the type of reproductive materials processed;
- The types of processing activities carried out by the processor or for which the processor is responsible, such as activities that are contracted out to a third party; and,
- Information demonstrating that the processor is in compliance with the AHR Act and its regulations.
In addition, it is being proposed that Health Canada may request additional information from the applicant to complete the review process. If it is deemed that the information provided is sufficient, satisfactory, and complete, the Minister will issue a registration number to the processor.
Any change in the information provided on the registration application must be communicated according to the following proposed timelines:
- Information about a change to the processor’s business information, civic address and contact details will have to be communicated to the Minister as soon as possible after the change is made;
- Information about a change in the type of reproductive materials processed and the types of processing activities conducted will have to be communicated to the Minister, who will issue an amended registration, in advance of making the change; and,
- Any cessation of regulated activities by the processor will have to be communicated to the Minister within 30 days.
Health Canada further proposes that, on an annual basis, processors who are registered with Health Canada will be required to complete and submit to the Minister a declaration attesting to their continued compliance with the AHR Act and its regulations. The declaration will confirm that the processor systematically monitors its compliance and implements preventive and corrective actions where considered necessary.
Under this proposed registration framework, the Minister will have the power to refuse to issue a registration number if there is reason to believe that any information provided on the form is false, misleading, inaccurate, or incomplete, or if the Minister has reasonable grounds to believe that issuance of the registration could compromise human safety or the safety of gametes intended for AHR. In addition, the Minister will also have the ability to require processors to submit any additional relevant information to demonstrate that the activities it conducts are in compliance with the AHR Act and its regulations at any point.
Finally, Health Canada is proposing that registrations may be cancelled by the Minister when a processor has informed the Minister that they have ceased regulated activities or if there are reasonable grounds to believe that the processor is not in compliance with the AHR Act and its regulations.
QUESTION FOR STAKEHOLDERS
Q2: Please explain, and support with scientific rationale, what level of regulatory oversight would be considered appropriate for fertility clinics that solely process directed donations. Should it differ from the processor registration framework proposed above?
Due the lower risk activities involved with importation and distribution, Health Canada is proposing that all importers and distributors, as defined above be required to notify the Minister, in writing, 30 days before the date on which they intend to begin importing or distributing, including storing for the purpose of distributing, donor sperm and ova. It is being proposed that notifications be required to include:
- Details about the importer's or distributor’s business information, civic address and contact details;
- Information about the processor(s) to be used by the importer or distributor;
- The types of reproductive materials being imported or distributed; and,
- The date on which the person will begin to import or distribute donor sperm and ova.
Any change in the information provided on the notification must be communicated according to the following proposed timelines:
- Information about a change to the importer’s or distributor’s business information, civic address and contact details will have to be communicated to the Minister as soon as possible after the change is made; and,
- Information about a change in the processor(s) being used by the importer or distributor and the types of reproductive materials being imported or distributed will have to be communicated to the Minister in advance of making the change.
As long as the importer or distributor has notified the Minister and continues to conduct that activity, Health Canada is proposing that no new notification is required. However, if the person ceases importing or distributing donor sperm and ova, including storing donor sperm and ova for the purpose of distribution, it is being proposed that they be required to notify the Minister within 30 days after they have stopped conducting regulated activities.
Finally, under this notification framework, persons in Canada who have notified Health Canada may import and distribute donor sperm and ova, including storing that donor sperm and ova for the purpose of distribution, originating from any processor (foreign or domestic) registered with Health Canada.
4.1.6. Establishment Requirements
To help ensure that gametes intended for AHR in Canada are safe, Health Canada is proposing the following establishment requirements for all processors, importers, and distributors of donor sperm and ova:
Establishments will be required to have sufficient personnel with the qualifications necessary to perform their assigned duties. Personnel may be qualified by education, training or experience (or a combination thereof). Establishments must have a system in place to provide personnel with initial and ongoing training and to evaluate their competency.
Establishments will be required to have facilities that are designed, constructed, and maintained so as to allow for the performance of all its activities, the efficient cleaning and disinfection to prevent contamination or cross-contamination, environmental and microbiological monitoring and control in all designated areas, and controlled access to all areas where its activities are carried out.
Equipment and Supplies
All establishments will be required to use equipment that is cleaned and maintained, qualified, calibrated, disinfected or sterilized appropriate to its use and impact to the quality of the sperm or ova. Equipment used to store gametes must maintain the validated storage temperature.
All establishments will be required to have a quality assurance system in place that complies with the requirements of the regulations and enables them to carry out all their activities. An important component of a quality assurance system is the standard operating procedures (SOP), which must be kept current, be approved by a qualified person, such as the Medical Director or Scientific Director (approval also required before the implementation on any subsequent changes as well), and available where relevant activities are carried out. Establishments will be required to review their SOPs every two years. An establishment will also be required to conduct an audit every two years of the activities that it carries out, by a qualified person who does not have direct responsibility for the activities being audited, to verify that those activities comply with the relevant regulations and with its SOPs.
Q3: Please explain if any of the establishment requirements listed above should not be applied equally for all persons engaged in regulated activities (processing, importing, and distributing) and why.
4.1.7. Processing Requirements
Sperm and Ova Processing Requirements
Health Canada proposes to introduce regulations for processing of sperm and ova intended for the use in AHR to ensure that sperm and ova are obtained, prepared, preserved, quarantined, identified, labelled and stored properly, and that their quality is assessed. In addition, Health Canada proposes that each processing establishment be required to develop and follow SOPs to ensure that they are processing donor gametes in accordance with the regulations. The disposal of donor gametes will also be done in accordance with the establishment’s SOPs.
Donor Suitability Assessment
Health Canada also proposes to develop regulations for assessing the suitability of potential donors of sperm and ova intended for the use in AHR. The proposed regulations will require that all sperm and ova donors be informed of the possible health risks associated with sperm and ova donation, prior to donation. In addition, all sperm and ova donors will be required to consent to having their donor suitability assessed, and their results disclosed, as deemed appropriate by the medical director or treating physician, to inform the recipient of any risks.
It is proposed that anonymous and directed sperm and ova donors be required to undergo a donor suitability assessment that includes the following requirements:
- Sperm and ova donors must be screened (based on their medical, social and genetic history) as per the proposed screening criteria outlined below.
- Sperm and ova donors must be tested for infectious disease agents, and for blood compatibility, as per the proposed testing criteria outlined below.
- A review of the donor’s overall suitability assessment must be conducted by a Medical Director or a physician designated by a Medical Director, and must include review of outcomes of the following: donor screening, donor testing and a physical examination (if required).
- Donor suitability assessment must be completed prior to the release of donation. Where donor suitability has not been completed, donations must be quarantined, clearly identified and easily distinguished from those for which donor suitability assessment has been completed.
Retesting of anonymous sperm donors for infectious disease agents 6 months after the date of donation is considered a part of donor suitability assessment. This retesting requirement will not apply to directed sperm donors and anonymous or directed ova donors.
QUESTION FOR STAKEHOLDERS
Q4: As part of the donor suitability assessment, should anonymous sperm and ova donors be excluded based on their upper age? If so, what is a reasonable upper age limit beyond which sperm and ova donations should no longer be accepted?
(Note: Section 9 of the AHR Act already prohibits obtaining sperm or ovum from a donor under 18 years of age, except in narrowly prescribed circumstances.)
Infectious Disease Screening
Health Canada is proposing that all sperm and ova donors be screened for infectious disease risk factors and that screening be repeated every 6 months while the donor is actively donating. While anonymous sperm and ova donors will be excluded from donation if they meet any of the exclusion criteria, directed donors will be permitted to donate under specific conditions outlined in section 4.1.4.
Health Canada is currently working with subject matter experts, including the CSA Technical Subcommittee responsible for maintaining and updating the Reproductive Tissues Standard, to develop evidence-based infectious disease screening criteria for sperm and ova donors.
Genetic Disease Screening
Health Canada proposes to introduce regulations that will require that appropriate and effective measures are taken to screen donors for the risk of genetic disease transmission. The intent of genetic disease screening is to assess the donor’s overall risk of genetic disease transmission, and make this information available to the treating physician and to the recipient.
Health Canada is proposing that sperm and ova donors be screened for the following:
- Presence of any major MendelianFootnote 2 disorder in the donor;
- Presence of any autosomal recessive disorder in the donor, known to be prevalent in the donor’s ethnic background, according to accredited/recognized national or international professional medical guidelines; and,
- Three generations of family genetic history for any autosomal recessive disorders known to be prevalent in the donor’s ethnic background, if known.
Anonymous sperm or ova donors who are known to have any major Mendelian disorders (autosomal dominant, X linked disorders, or autosomal recessive inheritance (homozygous)) or serious chromosomal abnormalities will be excluded, however, directed donors will be permitted to donate under specific conditions outlined in section 4.1.4.
Sperm and ova donors who are determined to be heterozygous (a carrier) for autosomal recessive disorders, will not be excluded. Depending on the pattern of inheritance of a particular genetic disease, in combination with other environmental factors, the medical practitioner will be able to assess the overall genetic risk based on the results of donor screening, and advise the recipient accordingly.
Health Canada would consider the use of genetic tests to reveal information that would otherwise be obtained as the result of donor screening to be an appropriate and effective measure to assess the risk of genetic disease transmission.
QUESTION FOR STAKEHOLDERS
Q5: Please explain whether or not Health Canada should provide additional criteria on genetic disease screening, including a list of serious genetic diseases that a donor of sperm or ova should be screening for and why.
Health Canada is proposing that all sperm and ova donors be tested to determine their blood compatibility (ABO and Rh status).
Infectious Disease Testing
Health Canada is proposing that regulations require all donors of sperm and ova be tested for infectious disease agents using appropriate test kits licensed in Canada. The use of test kits licensed in Canada or the United States will be permitted for testing done outside of Canada.
Anonymous donors of sperm or ova who test positive for any of the infectious disease agents listed below, with the exception of Cytomegalovirus, will be excluded from donating. Directed donors who test positive for any infectious disease agents may be permitted to donate under specific conditions (see section 4.1.4).
It is being proposed that testing be repeated every 3 months for directed sperm donors and anonymous or directed ova donors, while actively donating.
It is being proposed that sperm and ova donors be tested for the following infectious disease agents:
- Human immunodeficiency virus type 1
- Human immunodeficiency virus type 2
- Hepatitis B virus
- Hepatitis C virus
- West Nile virus
- Treponema pallidum (syphilis)
- Chlamydia trachomatis
- Neisseria gonorrhoeae
In addition, it is being proposed that sperm donors be tested for following infectious disease agents:
- Human T-lymphotropic virus type 1
- Human T-lymphotropic virus type 2
QUESTION FOR STAKEHOLDERS
Q6: Please list any additional infectious disease agents that should be tested for and explain the scientific interpretation for why they should be included.
Infectious Disease Retesting
It is being proposed that the regulations will require that sperm from anonymous donors be quarantined and the donor retested for infectious disease agents at least 6 months after the date of donation prior to the release and distribution of their donation. All other donors, including anonymous ova donors, will not require retesting as part of their donor suitability assessment.
Health Canada proposes that the regulations will require all processors of donor sperm or ova for distribution to maintain records of each donor. These records will include information that identifies the donor and the date of each donation, as well as the results of the tests, screening and donor suitability assessment.
It is being proposed that all importers and distributors of donor sperm or ova be required to maintain records that identify the entity from which the donation was received (i.e. a processor, an importer or another distributor). Importers and distributors will also be required to maintain records that demonstrate evidence that the sperm or ova were processed in accordance with the section 10 regulations as well as copies of any additional labelling required by the section 10 regulations in the case of directed donation and exceptional distribution.
Health Canada proposes that all users of the donor sperm or ova be required to maintain records that identify the patient on whom the assisted reproduction was performed. Additionally, in the case of directed donation or exceptional distribution, the regulations will require the person who makes use of the donor sperm or ova to maintain the patient’s written consent to use the sperm or ova.
Record retention requirements will also be established in the regulations.
Health Canada proposes that regulations with respect to tracing donor sperm and ova be introduced to identify persons who have imported, distributed, or made use of the donor sperm and ova, or who are storing the donor sperm and ova for the purpose of distribution or use in AHR, so that necessary steps can be taken in the event of:
- errors or accidents from processing and handling of donor sperm or ova that could affect their quality and safety; and,
- adverse outcomes to the recipient, potentially attributable to the use of donor sperm or ova.
In order to reduce the risk of potentially preventable adverse outcomes, as well as to mitigate the risks resulting from errors or accidents, Health Canada is proposing that the regulations require the communication of information to Health Canada and all other relevant parties along the distribution chain, which may include donors of the sperm and ova and the persons who have undergone AHR procedures in which the sperm or ova were used.
Health Canada proposes that the regulations also require an investigation of any suspected errors or accidents and adverse outcomes by the responsible party (to determine the nature, cause and extent of the risks to human health and safety) and, appropriate measures be taken in respect of the sperm and ova to reduce those risks.
Clear timelines will be established for the responsible party in reporting adverse outcomes and/or errors and accidents to Health Canada.
Did you Know?
While it is proposed that the new regulations will require that information pertaining to donor sperm and ova accompany the donations throughout the distribution chain from processor to the eventual recipient, the personal information of donors is not part of that information. Rather, the regulations will require the use of a donor identification code, which is an alphanumeric code that consists of unique donor identification and the date of donation. The donor identification code serves as a means to identify the donor without disclosing their identity and relates the sperm or ova to the donor and to all other records related to the sperm or ova.
QUESTION FOR STAKEHOLDERS
Q7: Please explain whether or not cases of suspected transmission of a genetic disease from donor sperm or ova should be reported to Health Canada and why. What would be the expectation for Health Canada’s role in assessing and taking action for such cases?
4.2. Section 12 Reimbursement
Sections 6 and 7 of the AHR Act prohibit the payment for surrogacy and the purchase of sperm and ova from a donor or a person acting on behalf of a donor, respectively. Despite these prohibitions, Parliament recognized that in order to promote an altruistic system, donors and surrogates should be permitted to be reimbursed for out-of-pocket expenditures incurred as a result of their donation or surrogacy. As such, section 12 of the AHR Act deals with the reimbursement of expenditures and loss of work-related income. Specifically, section 12 prohibits reimbursement except in accordance with regulations.
4.2.2. Principles and Objectives
The principles of reimbursements made under the AHR Act are as follows:
- Only expenditures incurred in the course of sperm or ova donation, in the maintenance or transportation of an in vitro embryo, or, for surrogates, in the relation to the surrogacy, including the loss of work-related income for surrogates, may be reimbursed.
- There is no obligation to reimburse, meaning that only persons who wish to reimburse eligible expenditures will do so.
- Reimbursement must not involve monetary gain by involved parties, nor should it be a disguised form of payment or purchase. AHR-related expenditures that are not specifically set out in the regulations are not eligible for reimbursement.
- A receipt for the expenditure must be provided to the reimburser as a condition of the reimbursement.
The objective of the reimbursement regulatory framework under the AHR Act is to provide parameters around the reimbursement of expenditures. For the most part Health Canada is proposing that this be accomplished in two ways:
- First, the regulations will set out categories of expenditures that could reasonably be incurred by a donor or surrogate as a consequence of their donation or surrogacy. This will have the effect of limiting reimbursements, as they will only be permitted for the categories of expenditures listed in regulations.
- Second, the regulations will specify a verifiable process by which reimbursements may be made. Specifically, they will require evidence that a reimbursement has been made in accordance with the Act and regulations, which is to be documented by the parties involved. This is to enable compliance enforcement activities, as well as to provide clarity and structure to the reimbursement process for stakeholders.
4.2.3. Scope and Application
The regulations will apply to all payments made to donors of sperm and ova for third party use for the purpose of reimbursing eligible expenses incurred in the course of the donation, to surrogates for the purpose of reimbursing expenses incurred in the course of surrogacy, and to persons for the purpose of reimbursing expenses incurred in the maintenance and transport of in vitro embryos.
Expenditures that may be reimbursed
It is proposed that the regulations will specify that the following expenditures are eligible for reimbursement:
For sperm and ova donors and surrogates
- Travel expenditures, including expenditures for transportation, parking, meals and accommodation
- Expenditures for the care of dependents
- Expenditures for counselling services
- Expenditures for legal services and disbursements
- Expenditures related to shipping (for sperm and ova only)
- Expenditures for other items or services that are provided by or recommended in writing by a qualified medical practitioner
For ova donors and surrogates
- Expenditures for medication
- Expenditures for maternity clothes
- Expenditures related to the delivery
For maintenance and transport of in vitro embryos
- Expenditures for storage of the in vitro embryos
- Expenditures for preparing the in vitro embryos for transport
- Expenditures for the shipping container and for preparing the container for transport
- Expenditures for transporting the in vitro embryos
QUESTION FOR STAKEHOLDERS
Q8: Please identify any other categories of expenditure that should be considered for reimbursement and explain why.
4.2.4. Process for Reimbursement
For the purpose of enabling compliance enforcement activities and to provide clarity and structure to the reimbursement process for stakeholders, Health Canada is proposing to establish a verifiable process by which reimbursements may be made.
Under the proposed process, a person will only be allowed to reimburse another person for an expenditure incurred as a result of their donation or surrogacy if the following documents are obtained:
- A declaration dated and signed by the person who requests reimbursement (i.e. the donor, the surrogate, or the person who maintained or transported an in vitro embryo);
- The receipt for each expenditure for which reimbursement is sought; and,
- If applicable, the written recommendation from a qualified medical practitioner.
4.2.5. Reimbursing a surrogate for the loss of work-related income
The AHR Act allows a surrogate to be reimbursed for the loss of work-related income incurred during their 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.
Health Canada is proposing that such reimbursements be permitted provided the loss has not otherwise been covered by another person, including the surrogate’s employer, and the loss is not greater than the amount the surrogate would have received during the period for which the reimbursement is claimed from their employer or self-employment.
A person will only be allowed to reimburse a surrogate for the loss of work-related income if the following documents are obtained:
- A declaration dated and signed by the surrogate who requests reimbursement;
- Proof of income to validate the claimed amount; and,
- A copy of the medical practitioner’s written certification.
4.2.6. Creation and Maintenance of Records
Health Canada proposes that persons who issue a reimbursement under section 12 of the AHR Act will be required to keep all forms, documents and receipts for a period of 6 years after the reimbursement is issued.
4.3. Section 45 to 58 – Administration and Enforcement
Sections 45 to 58 of the AHR Act were amended in 2012 to narrow their application to certain prohibitions (sections 8, 10, and 12 of the Act) and remove references to the AHRC, which was closed in 2012. The purpose of sections 45 to 58 is to establish a regulatory framework for compliance verification by designated inspectors, as well as and enforcement activities in relation to the Act.
Similar authority currently exists over donor sperm under the Food and Drugs Act. The safety of donor ova is currently unregulated at the federal level. Once sections 45-58 are brought into force, Health Canada will align its administration and enforcement oversight of AHR into a single regime.
4.3.2. Principles and Objectives
The administration and enforcement framework of the AHR Act is guided by the principles of regulatory transparency and a risk-based approach to compliance and enforcement.
The objective of the administration and enforcement framework under the AHR Act is to establish a comprehensive compliance verification regime that provides effective oversight over processors, importers, and distributors.
4.3.3. Scope and Application
Sections 45 to 58 of the AHR Act authorize designated inspectors to verify compliance with any of the requirements of sections 8, 10, and 12 of the AHR Act. Health Canada proposes that the administration and enforcement framework be designed to verify that consent is received from donors for reproductive material, that evidence based screening and testing standards are used for donor ova and sperm, that traceability is ensured for donor ova and sperm, and that the reimbursement of expenditures related to donation or surrogacy comply with regulatory requirements.
The administration and enforcement framework consists of four main components:
- Sections 46 to 53 authorize the Minister to designate inspectors to administer and enforce the AHR Act and outlines the powers of inspectors to verify compliance and address non-compliance, including the ability to enter a place or conveyance where they have reasonable grounds to believe an activity under the Act is being conducted, to examine any material or information regulated by the Act, and to seize any non-compliant material or information related to a contravention of the AHR Act;
- Section 54 sets out a requirement for Health Canada to take all reasonable measures to preserve any viable sperm, ovum or in vitro embryo that is seized under this Act or the Criminal Code;
- Sections 55 to 57 authorizes the Minister to designate analysts to administer and enforce the AHR Act and outlines the powers and responsibilities of analysts; and,
- Section 58 enables the Minister to establish agreements with other federal, provincial, or law enforcement departments and agencies for enforcement of the AHR Act.
Most of sections 45-58 will be brought into force with sections 10 and 12 without additional regulations, but there are three areas (sections 51, 52(3), and 54) that require additional regulations to be put into place.
4.3.4. Process for restoring seized information or human reproductive material
Under section 50, once entered into a place, inspectors will have the authority to seize, among other things, embryos and any other human reproductive material outside the body, as well as any information, if they have reasonable grounds to believe that the Act has been contravened or if it relates to a contravention of the Act.
Section 51 establishes notification requirements for a person applying to a provincial court for the restoration of material or information that was seized from them. In order for that material or information to be returned under section 51, persons are required to notify the Minister of their intention to apply for an order of restoration to a provincial court judge.
It is proposed that the notice will be required to be sent to the Minister 15 days before the application for an order of restoration is to be made to a provincial court judge and that the notice includes:
- Information on the time and location of the hearing;
- Information regarding the material or information seized; and,
- Evidence that will be used to establish the applicant is entitled to the material or information.
4.3.5. Defining designated officer under ss. 52(3) and 54
The concept of “designated officer” was introduced into the AHR Act in 2012 to replace former references to the “Agency” when the AHRC was closed. It is proposed that “designated officer” will be defined by the Minister.
4.3.6. Measures to maintain viable material when consent cannot be obtained
Section 54 requires the designated officer to make reasonable efforts, and in a manner that is consistent with the consent of the donor, to preserve any viable sperm, ovum, or in vitro embryo that has been seized under the Act or the Criminal Code. Although it is expected that further measures, which could include disposal, would be taken only exceptionally, such measures would be taken in a manner consistent with the consent of the donor. However, in those circumstances in which consent of the donor cannot be obtained, it is proposed that regulations will set out the parameters for such measures.
5. How to Submit Feedback
Comments regarding the policy proposals set out in this document may, within 60 days of the date of its publication, be submitted by:
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Address Locator 0601B, Tunney’s Pasture
100 Eglantine Driveway, Ottawa, Ontario
All feedback received on or before September 9 will be considered during the regulatory development phase of the project. Interested stakeholders will be given an opportunity to provide feedback on regulatory proposals following their prepublication in the Canada Gazette, Part I.
6.1 Appendix A: International Comparison of AHR Regulatory Oversight
|Canada||United States||United Kingdom|
|Governing Legislation||Assisted Human Reproduction Act (AHRA)||Title 21 Code of Federal Regulations (CFR) Part 1271 sets out regulations for the safety of use of donor sperm and ova at the federal level Other regulations of AHR technologies vary at the state level||Human Embryology & Fertilisation Act (HEFA)
In addition to HEFA, the Surrogacy Arrangement Act, prohibits commercial surrogacy
|Scientific procedures||AHRA prohibits certain procedures (e.g. germline modifications)||Prohibitions vary at the state level||HEFA prohibits certain procedures|
|Surrogacy||Commercial surrogacy is prohibited but altruistic surrogacy is permitted||Commercial surrogacy is not prohibited at the federal level||Commercial surrogacy is prohibited but altruistic surrogacy is permitted|
|Commercial trade of human ova, sperm and embryos donations||Prohibited to purchase sperm or ova from a donor or a person acting on behalf of a donor||Commercial trade is not prohibited at the federal level||Commercial trade is prohibited|
|Reimbursement of expenses incurred by surrogates and donors||Reimbursement of eligible expenses is legally permissible||Reimbursement of expenses is not applicable due to commercial trade||Reimbursement of expenses is legally permissible|
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