Health Canada Approves Héma-Québec Request for Individual Risk Assessment

Health Canada approved a request from Héma-Québec on Tuesday to replace donor eligibility criteria specific to men who have sex with men (MSM) with individual risk assessment for all donors, regardless of their sexual orientation. Hema-Québec expects to implement the new approach in early December.  

Currently, MSM who wish to donate blood with Héma -Québec must wait three months from their most recent sexual contact with another man. Under the revised eligibility approach, however, Héma-Québec will ask all donors about sexual behavior and pregnancy history. Those who report having a new partner within the past 3 months, or multiple partners, will be asked additional questions. 

Marc Germain, MD, PhD, vice president, Medical Affairs and Innovation, said that he does not expect the new approach to have a negative effect on the blood supply. “Our assessments and the results observed in the United Kingdom, which implemented a similar approach in June 2021, allow us to estimate that the new measure will have no negative impact on the supply,” Germain said. “Furthermore, this entire approach is based on scientific evidence, while maintaining a high level of safety for blood products intended for transfusion.”   

In March, Health Canada approved a submission from Héma-Québec to move to individual risk assessment for all source plasma donors and, the following month, approved a submission from Canadian Blood Services to move to individual risk assessment for all blood and plasma donors.  

These changes build upon previous reductions in the donor deferral period for MSM in Canada, which decreased incrementally from a five-year deferral in 2013 to a three-month deferral in 2019. According to Health Canada, these evidence-based reductions to the original lifetime restriction have not resulted in any increase in HIV-positive blood donations.