Regulatory Decision Summary for 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:

• Population-level risks of HIV, Hepatitis B and C and other viruses;
• Known infectious risks in the blood supply;
• Emerging infectious disease agents;
• Measures taken to reduce possible emerging infectious risks;
• MSM population demographics;
• Known infectious risks with emerging pathogens;
• International criteria for donor deferrals;
• Experience with gender-neutral risk behaviour-based criteria in other countries;
• Defined term deferral periods;
• Risk modeling;
• Compliance expectations;
• Demographic data and risk factors of HIV positive donors, July 2013 - April 1, 2015; and
• Impact on adequacy of blood supply; and
• Outreach and public consultation with key stakeholders.

The purpose of the MSM blood donor deferral is to help reduce the risk of transmitting Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) and Hepatitis C (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, and continued to account for the majority of cases for the next ten years. According to 2014 data from the Public Health Agency of Canada, 48.8% of all 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.

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), syphilis 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 prevents infected units of blood from entering the system, which is safer than retrieving an infected unit once it has been introduced. Reducing the deferral period for MSM to 1 year will sufficiently cover the window period for HIV, HCV, and HBV and address risks associated with window period donations made by MSM donors. A combination of donor testing and screening measures is necessary to safeguard Canadas blood system. This combination has been highly effective, with no cases of HIV transmission by blood transfusion in over 25 years in Canada.

Another safety consideration in support of a one-year MSM deferral period is that the monitoring of infectious disease markers by the blood operators (CBS and HQ) shows that, since the implementation of the five-year deferral period in 2013, there has been no increase in the number of donations testing positive for these markers, including markers for HIV, HBV and HCV. In addition there is no indication of any negative impact on donor compliance with the change to the five-year deferral period.

The authorization of this change brings Canada in line with several other countries which have implemented or are planning on implementing a one-year deferral period for MSM, including the United States, Australia, New Zealand, Great Britain, France, Sweden, Finland and the Netherlands. Studies performed in other jurisdictions have demonstrated a low stable rate of HIV positive donations before and after implementation of the one-year deferral policy.

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