Question Period Note: Blood Donor Deferral Policy and Related Research – Men Who Have Sex with Men (MSM)

• Health Canada funds research that could inform future changes to blood donation policies. This funding supports blood operators to generate the scientific data required to support a submission to Health Canada for regulatory authorization.

KEY MESSAGES

• Canada has one of the safest blood systems in the world.

• On December 15, 2021, Health Canada received a submission from Canadian Blood Services seeking authorization to remove the current three-month waiting period for men who have sex with men who want to donate blood. The submission proposes using sexual behaviour-based screening for all donors, regardless of gender or sexuality.

• The submission is being reviewed following the normal processes for blood submissions, which have a review target of 90 days.

• On September 16, 2021, Health Canada authorized Canadian Blood Services to implement behaviour-based criteria for MSM in the collection of source plasma. The change to behavior-based criteria will initially be implemented at two sites (Calgary, Alberta and London, Ontario) with the intention of further roll-out to other locations
IF PRESSED …
• Health Canada and the provinces and territories cannot mandate a policy change to donor screening requirements except in extraordinary situations when safety issues arise.

• Canadian Blood Services and Héma-Québec must make submissions to Health Canada demonstrating the change’s potential benefit and safety based on up-to-date scientific data. Without this evidence, the current screening policies cannot be changed.
IF PRESSED ON THE KARAS’ HUMAN RIGHTS COMPLAINT …
• The Attorney General of Canada filed an application for judicial review of the September 25, 2019 decision of the Canadian Human Rights Commission, which was dismissed by the Federal Court on June 10th, 2021.The purpose of the judicial review that Health Canada had requested was not to stop or pre-empt the inquiry in the Canadian Human Rights Tribunal from proceeding, but rather to correctly establish the proper parties in the case. As the matter is presently before the Tribunal, any further details of Health Canada’s position will be provided to the Tribunal.
IF PRESSED ON WHETHER HEALTH CANADA ORDERED A 2-YEAR WAIT BETWEEN BLOOD BAN POLICY CHANGES …

• The blood establishments were required to monitor and report on the safety of the blood system following the implementation of each change to their MSM donor deferral policies; however, a 2-year minimum monitoring period prior to filing subsequent changes was not a condition of Health Canada’s authorizations

In Canada:
Canadian Blood Services (CBS) and Héma-Québec (H-Q) were created as arm’s length organizations responsible for operating Canada and Quebec’s blood systems. Under Canada's Blood Regulations, they are required to make submissions to HC for any changes to their policies, such as changes to donor deferrals. These submissions must include scientific data that support the safety of the proposed changes. HC assesses and authorizes any changes before they can be implemented, but has no authority to mandate that a donor screening criterion be changed, except in extraordinary situations when safety issues arise.

The first MSM deferral in 1984 prohibited a man who had engaged in sex with another man even once since 1977 from donating blood. On May 22, 2013, HC authorized a request from CBS and H-Q to change its MSM deferral criteria to a five-year deferral period and on June 16, 2016 HC authorized subsequent proposals from CBS and H-Q, to change the blood donor deferral period for MSM from a five-year to a one-year deferral period. On April 30, 2019, HC authorized a submission from CBS and H-Q to further reduce the MSM deferral period to three-months.

Funding research is the federal lever available to support further changes to blood donation policies. In 2016, the Government allocated $3.0 million for research to strengthen the evidence base supporting a non-discriminatory approach to blood donations. Budget 2019 further provided $2.4 million over three years, starting in 2019–20, for additional research specific to reducing barriers to the donation of blood plasma. Under Health Canada’s MSM Blood and Plasma Research Program, ongoing since 2016, Canadian Blood Services is overseeing eighteen (18) funded research projects selected through peer review processes. Among the funded studies, alternative donor eligibility questions and criteria are under evaluation for MSM. To date, twelve (12) projects have been completed, while six (6) projects are on track to achieve expected results.

On September 16, 2021 HC authorized CBS to implement behaviour-based criteria for MSM for collection of source plasma. CBS intends to implement behavior-based criteria at two sites (Calgary, Alberta and London, Ontario) prior to further roll-out. Part of the evidence used by CBS to support the plasma submission comes from results of the studies funded by HC.

On December 15, 2021, Health Canada received a submission from CBS seeking authorization to change its approach to blood and plasma donor screening. The submission proposes to move away from the current three month donor deferral period for all sexually active men who have sex with men, and to instead screen all donors, regardless of gender or sexuality, for high-risk sexual behaviour. The submission is being reviewed following the normal processes for blood submissions, which have a review target of 90 days. Pending approval, CBS expects the implementation of the new screening processes would take up to six months, which is based on the UK experience.

International trends:
There is no international scientific consensus regarding donor deferral periods for MSM. Some countries, such as China and Lebanon, maintain permanent deferral periods, while other countries, including France and Denmark adopted 4-months deferral periods. In Spain and Italy there is no MSM deferral period, rather donors are screened for higher risk activities such as having sex with more than one concurrent partner, or sex with an occasional partner. Others have adopted a 3-month deferral including the United States (April 2020), New Zealand (December 2020) and Australia (January 2021). In June 2021, the UK implemented changes that lift the MSM blood donation deferral and move to behavioural screening based on evidence-based recommendations The Netherlands is also moving towards behavioural-based screening, and in September 2021 started allowing MSM in monogamous relationships to donate blood.

KEY FACTS

• Our government has been working on reducing barriers preventing MSM from donating blood by:

o authorizing Canadian Blood Services’ and Héma-Québec’s proposals to reduce the deferral period for donation from five years to 3 months;

o committing $3 million to Canadian Blood Services, starting in 2016, and in collaboration with Héma-Québec, to further advance research on this issue, and

o providing a further $2.4 million over three years, starting in 2019–20, for additional research specific to reducing barriers to the donation of plasma.