2024-03-12 19:00:00
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These guidelines outline the essence of Health Canada’s interim approach to implementing certain requirements of the directed donation process. They are aimed at:
to healthcare professionals who use donor sperm or eggs to establishments that process, import, distribute or use donor sperm or eggs
The Regulations on the safety of sperm and ova (the Regulations) made under the Law on assisted procreation (the Act) applies to donor sperm or eggs that are used for assisted reproduction.
The Regulations offer multiple donation avenues. One of these avenues is the directed giving process. This pathway provides flexibility and autonomy to individuals for donor selection in situations where the donor and recipient know each other. It also guarantees the safety of the donation while allowing the use of sperm or eggs from known donors who would otherwise be excluded under the regular process.
Health Canada has recently been made aware that certain requirements set as part of the directed donation process do not take into account current industry practices. They also do not take into account certain situations relating to intended parents who need a substitute parent to have children.
It is becoming increasingly common for regulated parties to use donor sperm or eggs in the creation of in vitro embryos (IVEs) for intended parents before they even know their surrogate parent. Here are some reasons that may explain this situation:
Advances in VIE cryopreservation techniques Challenges and delays associated with choosing a surrogate parent Desire to know that viable VIEs are available before entering into an agreement to carry the pregnancy with a surrogate parent
Gametes from intended parents are sometimes processed under the directed donation process. This is done because the donor(s) will know the recipient (the surrogate parent) later. However, the recipient is not known at the time of using donor sperm or eggs.
By doing so, regulated parties are not complying with:
certain key requirements of the directed donation process, including that: the donor and recipient must know each other before the sperm or eggs are used certain recipient obligations must be met before the sperm or eggs are used
The requirement for intended parents to know their surrogate parent before using sperm or eggs for the creation of EIV has multiple unintended consequences, including:
the possibility of creating an unnecessary and potentially costly burden by requiring intended parents to have their sperm or eggs collected and cryopreserved instead of using fresh gametes for VIE creation the possibility of undue delays in gamete collection (in cases where the use of fresh gametes is necessary), which might impact fertility risks limiting access to a specific subset of donors who may not be eligible to donate in the context of the regular process
This is contrary to the intent of the directed giving process which aims to increase access and flexibility.
Therefore, until the Regulations can be amended to resolve this problem, Health Canada will temporarily consider certain requirements of the directed donation process to be of low priority for the application of the law. However, conditions apply to this restricted situation.
Policy objectives
Health Canada recognizes that the Regulations must be amended to address situations involving all the following factors:
Intended parents know they will need a surrogate parent to have children Intended parents wish to create and cryopreserve EIVs using gametes processed following the directed donation process Intended parents wish to create of EIV before knowing their surrogate parent
This interim enforcement approach will avoid limiting access to the directed donation process for donors who cannot donate through the regular process. This approach to enforcement, which will continue to reduce risks to human health and safety, is consistent with one of the key principles underpinning the Act. This principle, affirmed by Parliament, is that “people seeking to use assisted procreation techniques must not be discriminated once morest, in particular on the basis of their sexual orientation or their marital status”.
Scope and Application
The interim enforcement approach concerns:
healthcare professionals who use donor sperm or eggs facilities that process, import, distribute or use donor sperm or eggs in accordance with the directed donation process
Implementation conditions
Section 30 of the Regulations exempts donor sperm and eggs from the regular process. These gametes can be processed under the directed donation process if certain requirements are met. One of these requirements, defined in paragraph 30(a), is that the donor and recipient know each other.
For directed donations, section 40 of the Regulation requires that, before using sperm or ova, health professionals must record in a document the 2 following elements:
That in their medical opinion, the use of the sperm or eggs will not present a serious risk to human health and safety That they have informed the recipient of the health risks that the use of the sperm or eggs might pose and human safety and have obtained the written consent of the recipient
An interim approach to the application of paragraph 30(a) and section 40 with conditions is taken in relation to the directed donation process. This approach will be used in cases where the intended parent(s) know they will need a surrogate parent to have a child, but wish at a time :
use sperm and eggs to create an EIV have 1 or 2 gametes processed according to the directed donation process before knowing their surrogate parent
In such situations, Health Canada will consider non-compliance with paragraph 30(a) and section 40 of the Regulations to be of low enforcement priority. However, the risk mitigation conditions below must be respected:
In the event of non-compliance with paragraph 30(a), the donor and recipient must know each other before transferring the EIV to the recipient (surrogate parent) In the event of non-compliance with section 40, the health professional must comply with the following conditions before transferring the EIV to the recipient (surrogate parent). The healthcare professional must: create a document certifying that, based on the summary document and any risk mitigation measures with respect to the sperm or egg used in the creation of the EIV, their opinion medical is that the sperm or egg would not present a serious risk to human health and safety as a result of the transfer create a document attesting that as such he: informed the recipient of the risks that the use of the sperm or of the egg in the context of the transfer of the corresponding EIV might pose for human health and safety has obtained the written consent of the recipient
Health Canada has considered the implications of implementing this enforcement approach on the rest of the regulatory framework. If the conditions are met, non-compliance with paragraph 30(a) and section 40 and any other provisions as a result of that non-compliance will be considered low priority for enforcement purposes. . All other provisions of the Regulations regarding the directed donation process must, however, be respected before the sperm or egg can be used for the creation of an EIV.
Health establishments and professionals must demonstrate that the conditions have been respected. Applicable documentation and records, including standard operating procedures, may be verified during an inspection.
This enforcement approach takes effect immediately.
We will review this enforcement approach at regular intervals. We reserve the right to enforce the Law and Regulations if we detect possible risks to health and safety.
General note regarding the set of guidelines
The guidelines are intended to provide guidance to the industry and healthcare professionals on how to comply with applicable laws and regulations. They also provide advice to Health Canada staff on how to fulfill mandates and objectives in a fair, consistent and effective manner.
Guidelines are administrative means, not legal instruments. This means there is room for flexibility. However, to be acceptable, approaches that differ from the principles and practices described in this document must be supported by adequate justifications. They must be discussed in advance with the relevant program sector, in this case the Biologics Compliance Program, to verify that they comply with the applicable legislative or regulatory requirements.
Contact U.S
Please send any questions and requests for information regarding this interim enforcement approach to the Biologics Compliance Program by email at [email protected].
1710393159
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