Health Canada is seeking feedback about proposed regulations for sections 10, 12 and 45-58 of the Assisted Human Reproduction Act (AHRA). We here at the LGBTQ Parenting Network and Rainbow Health Ontario have prepared a summary of what they are looking at, followed by a little history.
(For full details on Health Canada’s current regulatory project and to submit feedback CLICK HERE. Feedback is due by Sept. 9, 2017.)
Today, an increasing number of Canadians are turning to AHR technologies to grow or build their families. A 2012 Canadian study 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.”
Health Canada, 2017
Whether we need sperm, eggs or a place to grow an embryo, the AHRA affects the equitable treatment of anyone seeking assisted reproductive technologies and services to have children in Canada. LGBTQ people are heavily represented among users of assisted human reproduction and are key stakeholders in the equitable formation of the regulations included in the AHRA. We believe there is significant value in Health Canada hearing your recommendations based on your experiences.
Inside Health Canada’s document you will find a mix of guiding principles, several specific questions for comment, and a number of proposals under development. What needs to be written into this current regulatory project so that the policies and practices of all those providing and using these services reflect current science, human rights obligations and ethics around compensation?
About The Sections Currently Under Review
Section 10: Safety of Donor Sperm and Ova
- Is designed to reduce the risks to human health and safety that might arise from the use of sperm or ova for the purposes of assisted human reproduction
Section 12: Reimbursement (of expenses for donors and surrogates)
- Sets the limits for what types of expenses are eligible for reimbursements for donors and surrogates
Sections 45-58: Administration and Enforcement
- Establish a regulatory framework for compliance and enforcement
Challenges and Opportunities
Based on prior stakeholder feedback, Health Canada now notes the need for:
Product Safety (Section 10):
- Evidence based screening and testing requirements for sperm and ova donors
- Regulatory requirements for processing, handling and quarantining of donated ova
Reimbursement (Section 12):
- Clarity on type and nature of expenses incurred by donors and surrogates that may be reimbursed
- A reimbursement process that is not overly burdensome
Administration and Enforcement (Sections 45-58):
- A comprehensive compliance system that has oversight over importers, processors and distributors
- Transparent auditing and inspection systems and effective complaint handling
Questions for Consideration
Health Canada asks several very specific questions in their current call. Topics include:
- Directed sperm/egg donations, exceptions to regulatory oversight and scientific rationale
- Anonymous sperm/egg donor suitability and upper age range
- Criteria for infectious disease testing and genetic screening of donors and scientific rationale
- Reporting donors suspected of transmitting genetic diseases
- Allowable expenditures for egg and sperm donors as well as for surrogates.
Read Health Canada’s call for their specific questions.
The LGBTQ AHRA Working Group, supported by the LGBTQ Parenting Network, made a submission to an earlier call for consultation from Health Canada. See the appendix below. As you consider your responses to the current regulatory project, we recommend you also read the appendix below.
We also offer a few more questions to keep in mind when reviewing this and future calls about the Act.
- Where in the AHRA does Health Canada differentiate Directed Donors from Intended Parents who are egg or sperm providers? Where might it be necessary?
- Where in the current regulatory project will Health Canada discuss Intended Parents who are egg or sperm providers and the safety of and issues around using their “products” (eggs/sperm/embryos)?
- Where and how might it be necessary to honour their health and safety?
- Where and how might it be necessary to honour the health and safety of their family expansion partners (e.g. Carrying Co-parent, Carrier/Surrogate)?
- Where in the AHRA are Intended Parents/Gamete Providers who are HIV positive supported?
- Where in the current regulatory project do they discuss Intended Parents who are egg or sperm providers who are HIV positive and the safety of and issues around using their “products” (eggs/sperm/embryos)?
- How will health discoveries and the protection of known or directed donor medical record privacy and consent to share with intended parents be explicitly written into the AHRA? (see Section 4.1.7 – Processing Requirements)
- What further ethical and pragmatic concerns need to be taken into consideration around the limited scope of reimbursement provisions for surrogacy? (see Section 4.2.3 – Expenditures That May Be Reimbursed)
- Where will the AHRA outline the licensing and regulating mechanisms for surrogacy agencies?
- The Ottawa Charter for Health Promotion outlines foundations of health and wellness, which include social justice and equity. How are social justice and equity for all stakeholders reflected in the AHRA?
- What needs to be written to ensure that processors, importers, distributors, users and qualified medical practitioners understand and practice within the guidelines of the Human Rights Act and provincial and territorial human rights legislation?
- The Human Rights Act explicitly protects the rights and freedoms of trans people through the recent passing of Bill C-16. What needs to be written into any sections of an updated Assisted Human Reproduction Act to reflect the rights, freedoms, experiences and needs of trans people seeking assisted human reproduction services?
- Whose needs, experiences and voices are still excluded in the framing and the language used throughout?
Send Health Canada Your Submissions and Comments
Health Canada asks that you send your submissions and comments by Sept. 9, 2017, according to the instructions on their website.
Appendix: A Little History
In response to an earlier call for consultation, the LGBTQ AHRA Working Group made a submission to Health Canada in November of 2016. The Working Group was comprised of members of the LGBTQ Parenting Network, Toronto physicians, nurses, fertility counsellors, midwives, community development workers, lawyers, researchers and former fertility clients. They outlined historic and current implications for LGBTQ individuals and communities in the areas of:
- safe use of reproductive tissues in assisted human reproduction
- reimbursement of surrogates and egg and sperm donors
- criminalization of assisted human reproduction
- limitations on access to assisted human reproduction.
The submission’s recommendations support several of the needs and experiences of people and families of all sexualities and genders looking to use assisted human reproduction—both within and outside of LGBTQ communities. Below we have pulled out a few highlights relevant to the sections currently under review. For the full submission, click here.
Working Group Highlights Related to Section 10
In their November 2016 submission, the Working Group raised concerns surrounding the regulations for the safe use of reproductive tissues (section 10) and the following elements of the Act:
At this time, we urge Health Canada to carefully consider the heteronormative assumptions currently embedded within the semen regulations in implementing changes to these provisions. The new Section 10 of the Act must not be based on HIV stigma, and instead be firmly grounded in current, accurate medical science. In the current drafting of the new Section 10, we are concerned that donor sperm, eggs, and embryos are treated similarly, despite presenting different medical risks, both physical and psychological, to recipients and to the embryos, fetuses, and children born through gamete donation.
Broadly we support:
- Eliminating the requirement to quarantine sperm in the case of a known or directed donor. We do not support adding restrictions to quarantine eggs and embryos.
- Increasing access for people living with HIV, their partners, and people acting as surrogates on behalf of people living with HIV, to pursue assisted human reproduction.
- Eliminating restrictions on men who have sex with men from being sperm donors.”
LGBTQ AHRA Working Group, 2016
Working Group Highlights Related to Section 12
The Working Group also expressed concern over the narrow and restrictive scope of expenses deemed eligible for reimbursement, particularly for surrogates:
The principle that guides reimbursement should be that egg, sperm, embryo donors, and people acting as surrogates, should not incur any expense or cost in the process of surrogacy or gamete donation.
Intended parents, someone acting on behalf of intended parents or gamete recipients, or a gamete bank, should be able to reimburse or pay for any cost or expense that the donor or surrogate incurs as a result of the donation or surrogacy that would not have otherwise been incurred. We recommend that the regulations provide appropriate guidance in each situation, and flexibility, particularly in the case of egg donors and surrogates.
Particularly in surrogacy and egg donation, the definition of reimbursable expenses should be sufficiently broad to allow reimbursement for loss of work-related income for any absence directly connected to the surrogacy or the donation. People acting as surrogates and gamete donors should not be subsidizing the costs of the surrogacy or gamete donation. The Act seeks to promote and support the altruistic surrogacy, egg, sperm and embryo donation, but to not reimburse lost income would penalize the people involved.”
LGBTQ AHRA Working Group, 2016
The latest Section 12 reflects a wider breadth of coverage for expenses and loss of work-related income. However, there continue to be gaps in coverage over what is considered an eligible expense.
A few examples of these are:
- maternity clothing
- coverage of expenses incurred by a support person during the term of surrogacy and recovery period after birth
- the Act does not specify when the process around donation begins and ends, leaving uncertainty as to when eligible expenses could begin to accrue