Regulatory Decision Summary for Modification of MSM Blood Donor Deferral

The decision to authorize this change was made further to a thorough review of the submissions from CBS and HQ. Pursuant to section 9 of the Blood Regulations, Health Canada reviewed scientific data and information submitted by the blood operators, which included:

• Data on population-level risks of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) and other viruses;
• Donor demographics and data, including risk factors for HIV-positive donors;
• A mathematical model for HIV residual risk estimation; and
• Outreach and consultations with key stakeholders.

The purpose of the MSM blood donor deferral is to help reduce the risk of transmitting HIV, HBV, and HCV via blood components. The deferral addresses the fact that, based on public health surveillance data, the prevalence and incidence of HIV is considerably higher in the MSM population compared to the general population. When HIV reporting began in 1985, the MSM exposure category accounted for over 80% of all cases. According to 2018 data from the Public Health Agency of Canada, 46.4% of newly-reported HIV cases in adults (≥ 15 years old) were attributed to the MSM exposure category. Risks for HBV and HCV are also higher in the MSM population than in the general population; however, male-to-male sex is not considered one of the main risk factors for either of these infections.

Canadas blood system is safeguarded through a combination of donor screening and blood sample testing. This combination has been highly effective, with no cases of HIV transmission by blood transfusion in over 25 years in Canada. In Canada, every blood donation is tested for HIV1/2, HCV, HBV, as well as Human T-cell lymphotropic virus I and II (HTLV I/II), and West Nile Virus (WNV). There is also redundancy in testing, with more than one type of test being used to detect HIV, HCV and HBV.

Because of better testing methods, the window period of the tests used to detect HIV and HCV have been reduced to less than 10 days. The window period for HBV is less than 30 days. This is the period of time between infection and possible detection of a pathogen with a blood test, during which there is a risk that infected units of blood may not be identified by testing. However, donor screening and deferral further prevents infected units of blood from entering the system in the first place, which is safer than retrieving an infected unit once it has been introduced. The scientific evidence presented in the submission demonstrates that reducing the deferral period for MSM to three months will sufficiently cover the window period for HIV, HCV, and HBV and address risks associated with window period donations made by MSM donors.

Another safety consideration in support of a further reduction of the deferral period for MSM is that the monitoring of infectious disease markers by the blood operators (CBS and HQ) shows that since the implementation of both the five-year deferral period in 2013 and the one-year deferral period in 2016, there has not been an increase in the number of donations testing positive for HIV, HBV or HCV.

The authorization of this change brings Canada in line with other countries which have implemented a three-month deferral period for MSM, including England, Scotland and Wales.

Taking into account the scientific data, stakeholder consultations, the potential benefit to the blood supply in terms of increased number of eligible donors, and the proposal by the blood operators for a post-implementation plan, it was concluded that, pursuant to the Blood Regulations, the proposed change to a three-month MSM deferral period will not compromise human safety or the safety of the blood supply.