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 blood or plasma. The purpose of this authorization amendment from Héma-Québec is to change the eligibility criteria for the collection of source plasma (plasma used for medical treatments and drugs) to risk based sexual behaviour criteria that will apply to all donors, regardless of their gender or sexual orientation.
Why was the decision issued?
The safety of the Canadian blood supply is assured by a combination of measures, including the rigorous selection of donors and the testing of the donated blood by both serologic and nucleic acid tests, in order to detect infectious agents which are transmissible by blood transfusions, such as the Human Immunodeficiency Virus (HIV), the hepatitis B virus (HBV) and the hepatitis C virus (HCV).
Currently, HQ requires that men are deferred (have to wait) for three months after their last sexual contact with another man before they can donate blood or plasma. This deferral is meant to reduce the probability that donors who are at high risk for certain blood borne and sexually transmitted infections can donate. However, it is high-risk behaviours, and not sexual orientation, which determine the risk of transfusion related transmission of infectious agents, like HIV.
The questionnaire for all donors of source plasma destined for fractionation has been revised to include behaviour-based criteria. The updated questionnaire contains new questions, which ask about the donor’s number of sexual partners as well as participation in anal sex during the three months before the donation date. According to studies, anal sex is the most important risk factor for transmission of blood and sexually transmitted infections.
Donors who have had multiple sexual partners or a new sexual partner and have had anal sex during the previous three months will not be eligible to donate source plasma for fractionation for three months following the last time they had anal sex.
Eligible plasma donations, such as from donors who have met all the eligibility criteria, and those with negative test results for infections of concern like HIV, HBV and HCV, will be sent for fractionation and used for the manufacturing of specialized medical treatments and drugs. It is important to note that the processing of the plasma involves a combination of methods, including purification, inactivation and pathogen reduction, which are extremely effective.
A study using modelling and simulation was done to estimate the residual risk of HIV in the Canadian blood supply, under no deferral scenarios for MSM donors. According to this study, after treatment with pathogen inactivation technology, there would be no infectious viral load out of 2 billion donations.
Based on the data provided, the new risk based sexual behaviour criteria that will apply to all donors, regardless of their gender or sexual orientation, are acceptable. This application will be followed by another one, which will assess the operational changes. Once the operational changes are assessed and considered acceptable, Héma-Québec will implement the authorized donor screening criteria.
Decision issued
Approved; Notice of Authorization Amendment with Conditions.