Expert review of new sexual behaviour-based screening practices

On December 15, 2021, Health Canada received a submission from Canadian Blood Services (CBS). CBS wanted to:

• remove the 3-month donor deferral period for sexually active men who have sex with men
• replace it with behaviour-based screening questions

Health Canada sought to obtain external expertise and advice on specific scientific and technical questions that came up during the review process. We convened a group of experts with a wide range of backgrounds and knowledge in health-related fields. The experts volunteered their time and we reviewed any potential conflicts of interest before engaging them.

The 6 experts reviewed the new sexual behaviour-based screening criteria submitted by CBS. The criteria will apply to all potential blood and plasma donors in Canada.

The goal of the new criteria is to make the rules more inclusive for men who have sex with men without compromising the safety of the blood system.

Experts included:

• Maître Michel T. Giroux, Chair (lawyer and ethicist, Institut de consultation et de recherche en éthique et en droit)
• Dr. Gilles Lambert (physician and medical consultant, National Institute of Public Health of Quebec)
• Dr. Alan Tinmouth (physician, clinical epidemiologist, director, The Ottawa Hospital Research Institute and division head, The Ottawa Hospital)
• Dr. Jacob Pendergrast (hematologist and medical director, Blood Transfusion Service, University Health Network, Toronto)
• Dr. James Neuberger (consultant physician, Queen Elizabeth Hospital Birmingham, United Kingdom)
• Dr. David Moore (physician and research scientist, B.C. Centre for Excellence in HIV/AIDS)

Together, they provided scientific, medical and technical advice on:

• statistical analysis and risk modelling
• the latest epidemiological information on sexually transmitted and blood-borne infections in Canada
• relevant public health considerations as they apply to recipients of blood and blood products

Health Canada posed specific questions to the experts on:

• the reliability of the statistical model, associated assumptions and estimated risk
• whether there is sufficient evidence to implement the new donation criteria at this time
• whether more questions should be added to the screening questionnaire to further reduce risk
  • including those related to "Chemsex" (taking certain psychoactive recreational drugs such as crystal meth during sex)
• how to address concerns expressed by some patient groups and
• whether the monitoring measures will sufficiently assess the impact of the proposed changes on the safety of the blood supply

The experts indicated that the proposed modelling was acceptable and that the estimated risk was extremely low and not significant. They also concluded that the new screening criteria do not affect the safety of the blood system compared to the current 3-month deferral.

The experts determined that the post-implementation data from other countries, such as the U.K., that have implemented similar screening criteria wouldn't provide additional useful data. This was due to the very small HIV residual risk identified by the model.

The experts agreed that participating in non-monogamous relationships is a risk factor for acquiring HIV. However, most of the experts indicated that detailed questions related to a donor's partner's sexual behaviour:

• would be problematic
• wouldn't be practical and helpful
• wouldn't compromise the safety of the blood supply if they weren't asked
  • according to data from the "For Assessment of Individual Risk" (FAIR) study conducted in the U.K.

The experts supported the post-implementation monitoring plan proposed by CBS with no changes.

Although the group of experts provided advice to Health Canada, we were responsible for the decision on the CBS submission.

Related links

• Health Canada authorizes Canadian Blood Services submission to eliminate the blanket donor deferral period for men who have sex with men
• Blood safety in Canada
• Regulatory decision summary
• Health Canada authorizes Héma-Québec submission to make source plasma donor screening criteria more inclusive for men who have sex with men