Regulatory Decision Summary for Transitioning toward a gender-neutral questionnaire focusing on at-risk behaviour for all donation types
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Currently, at Héma-Québec, men who have sex with men (MSM) must wait three months (i.e., are deferred) after their last sexual contact with another man before they can donate blood. The goal of this submission is to implement eligibility criteria based on behaviour at risk for transmission of infectious agents through transfusion, for all donors making donations, regardless of their gender or sexual orientation.
Why was the decision issued?
The safety of the Canadian blood procurement system is based on a combination of measures, which includes the thorough screening of donors, and the testing of donations using serology and nucleic acid screening tests to detect infectious agents that may be transmitted through transfusion, including the human immunodeficiency virus (HIV), the hepatitis B virus (HBV) and the hepatitis C virus (HCV).
Currently, at Héma-Québec, men must wait three months (i.e., are deferred) after their last sexual contact with other men before they can donate blood. The purpose of this deferral is to reduce the likelihood of collecting from donors at high risk for certain sexually transmitted and blood-borne infections. However, it is the at-risk behaviour, and not sexual orientation, that may determine the risk of transmission of infectious agents, such as HIV, through transfusion.
To apply eligibility criteria based on behaviour at risk for transmission of infectious agents through transfusion to all blood donors, the blood donation questionnaire is being revised. This revision consists of adding new questions about the number of sexual partners and about anal sex in the three months before the donation. According to the studies, anal sex is the greatest risk factor for transmission of HIV.
Donors who have had multiple sexual partners, AND anal sex in the last three months will be deferred from donating for a period of 3 months following the last anal sexual contact.
Donations from eligible donors, namely those who have satisfied all of the eligibility criteria, and for whom the results of the screening tests are negative for infectious markers, such as HIV, HBV and HCV, will be permitted.
A modelling and simulation study evaluated the risk of HIV infection in Canada from blood donation taking into account new deferral criteria. Based on the results, the risk of HIV infection was 1 in 20.7 million donations.
Note that a group of scientific experts, previously consulted for a similar change, supported the proposed change and is of the opinion that the risk of HIV infection based on the simulation results was extremely low.
Based on the information provided, the new screening criteria for all donation types, based on sexual behaviour at risk for transmission of infectious agents rather on the donor’s gender and sexual orientation, are acceptable.
Héma-Québec will follow-up to evaluate these changes.
Decision issued
Approved; Notice of Authorization Amendment with Conditions