Regulatory Decision Summary for MSM Plasma Donor Deferral
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, men who have sex with other men (MSM) have to wait for a three-month period (deferral) since their last sexual contact with other men before being able to donate plasma. The purpose of this authorization amendment from Canadian Blood Services (CBS) is to remove the waiting time for the collection of source plasma (plasma to be used as a source for medical treatments/drugs) for MSM. This would expand the donor pool for source plasma donation, at a time when CBS is aiming to increase source plasma collections considerably over the next few years.
In place of the time-based waiting period, the donors eligibility will be based on behaviour-based criteria using additional questions in the donor questionnaire. These changes will be implemented at two collection centres in London, Ontario and Calgary, Alberta. Plans to implement the approach at other sites in Canada are expected to follow in the future.
Why was the decision issued?
Currently MSM have to wait a three-month period (deferral) since their last sexual contact with other men before being able to donate blood/plasma. The deferral is based on a positive response to the following question: "In the last 3 months, have you had sex with a man?"
To remove the waiting period, a revision of the donor questionnaire has been implemented which includes the following two additional behaviour-based questions: "In the last 3 months, have you had a new sexual partner?" and "In the last 3 months, have you and your partner only had sex with each other?" These behaviour-based criteria are considered more appropriate than the time-based waiting period as they are more specific and address particular high-risk donors. Donors who respond with a negative answer to both questions will be considered to be in a mutually exclusive relationship with a stable partner in the last three months. If they also meet all the other eligibility criteria, the donor will be eligible to donate source plasma.
However, as a risk mitigation strategy, each donation will be kept in quarantine until the donor returns a minimum of 60 days later and has negative test results to infections of concern (e.g., human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV). At that time, the plasma will be sent for fractionation, inactivation of pathogens, and processing for future use.
A study evaluated the Canadian residual risk of HIV-positive source plasma incorporating pathogen inactivation (PI) under no MSM deferral scenarios for apheresis plasma donations through modelling and simulation. It was concluded that based on simulation results, there would be a negligible HIV residual risk associated with the removal of a time-based MSM deferral without quarantine for source plasma incorporating PI.
Decision issued
Approved; Notice of Authorization Amendment with Conditions