Health Canada authorizes Héma-Québec submission to make source plasma donor screening criteria more inclusive for men who have sex with men
March 24, 2022 | Ottawa, ON | Health Canada
Today, Health Canada authorized a submission from Héma-Québec to change their source plasma donor screening criteria. The decision will enable Héma-Québec to move away from the current three-month plasma donor deferral period for all sexually active men who have sex with men, and to instead screen all source plasma donors, regardless of gender or sexuality, for high-risk sexual behaviours.
Héma-Québec's submission included scientific information and risk modeling data to support the change to donor screening criteria. Source plasma donations undergo testing and other processing, including multiple pathogen inactivation steps, to significantly reduce the risk of contamination with infectious pathogens (e.g., viruses, bacteria, parasites).
Héma-Québec has indicated that the implementation of more flexible donor screening criteria for plasma could lead to a submission in the future to change the screening criteria for all types of blood donations.
Under Canada's Blood Regulations, the blood operators—Héma-Québec and Canadian Blood Services—are required to make submissions to Health Canada for any changes to their processes, such as changes to donor deferrals.
Health Canada is also currently reviewing a submission from Canadian Blood Services to use sexual behaviour screening for all blood and plasma donors instead of the current three-month donor deferral period for men who have sex with men.
The safety of donor blood and plasma recipients remains Health Canada's number one priority. Health Canada, as the regulator responsible for overseeing the safety of Canada's blood system, carefully reviews regulatory submissions to make sure any changes are based on robust scientific evidence and maintain Canada's high standards for safety.
The Department remains committed to supporting blood and plasma donation policies in Canada that are non-discriminatory and scientifically based.
More information on Health Canada's decision is available in its Regulatory Decision Summary.
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