Question Period Note: Blood donor deferral policy and related research

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• Canada has one of the safest blood systems in the world.
• On September 11, 2022, Canadian Blood Services eliminated the three month blanket donor deferral period for all sexually active men who have sex with men, and instead began screening all donors, regardless of gender or sexuality, for high risk sexual behaviour. This change towards a more inclusive screening was authorized by Health Canada on April 28, 2022. The Government of Canada provided $5.4 million, starting in 2016, in order to support the necessary research to effect this change.
• On December 4, 2022, Héma-Québec eliminated the three month blanket donor deferral period for all sexually active men who have sex with men, and instead began screening all donors, regardless of gender or sexuality, for high risk sexual behaviour. This change was authorized by Health Canada on September 6, 2022.
• On October 16, 2022, Canadian Blood Services implemented a number of changes to their donor deferral criteria. For example, CBS has eliminated the 12-month deferral period for non-intravenous drug users. Additionally, the deferral period for both donors who have taken money or drugs for sex and their sexual partners was changed from an indefinite deferral to a 12 month deferral, and the deferral period for those who have used steroids illegally was changed from 12 to 6 months. These changes were authorized by Health Canada on August 24, 2022.
• Both CBS and HQ have been authorized to implement sexual behaviour-based criteria for all source plasma donors, regardless of gender or sexuality on September 15, 2021 and March 24, 2022 respectively.

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 REDUCING BARRIERS FOR MEN WHO HAVE SEX WITH MEN …
• Our government has been working on reducing barriers preventing men who have sex with men (MSM) from donating blood by:
o authorizing Canadian Blood Services to eliminate the three month blanket 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.
o authorizing Héma-Québec to eliminate the three-month blanket 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 behaviours.
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.

IF PRESSED ON MONKEYPOX…
• At present, there are no known cases of transfusion transmitted monkeypox, but transmission by this route is theoretically possible.
• On June 6th 2022, Héma-Québec added a screening question on monkeypox to their donor questionnaire, due to the current outbreak in Montreal. Donors who have been in contact with a confirmed case of monkeypox in the last 6 months will be deferred from donating blood for 41 days.
• As of August 29th 2022, Canadian Blood Services added eligibility questions on monkeypox to their donor questionnaire. Anyone who has had monkeypox will be deferred for 42 days from the start of symptoms and anyone who has had contact with a monkeypox case will be deferred for 42 days since last contact.
• The Blood operators will continue to monitor the situation and will adapt as necessary to ensure the blood system remains safe.

IF PRESSED ON THE KARAS’ HUMAN RIGHTS COMPLAINT …
• 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 THE HUMAN RIGHTS COMPLAINT RELATED TO DEFERRAL OF THOSE WHO TAKE DRUGS OR MONEY FOR SEX…
• The complaint in question was withdrawn. Of note, on October 16, 2022, Canadian Blood Services made several changes to their donor deferral policies, including a change to the deferral for those who take drugs or money for sex, from a lifetime deferral to 12 months. These changes were authorized by Health Canada on August 24, 2022.

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.

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 Health Canada (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. Additionally, the government of Canada provides $5M annually to CBS to support research and development activities, which in turn can be used to support evidence generation needed for submissions from the blood operators.

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 requests from CBS and H-Q to change the 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 MSM 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 MSM research specific to reducing barriers to the donation of blood plasma. These contributions were in addition to the ongoing $5M funding to CBS. 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. Part of the evidence used by blood operators to support the following submissions came from results of the studies funded by the government of Canada.

On April 28, 2022, HC authorized a submission from CBS to eliminate the MSM deferral period, and instead screen all blood and plasma donors, regardless of gender or sexuality, for high-risk sexual behaviour. CBS implemented the new screening criteria on September 11, 2022.

On September 6, 2022, HC authorized a submission from H-Q to eliminate the MSM deferral period, and instead screen all blood and plasma donors, regardless of gender or sexuality, for high-risk sexual behaviour. H-Q implemented the new donor screening approach on December 4, 2022.

On March 24 2022, HC authorized H-Q to eliminate the three-month plasma donor deferral period for all sexually active men who have sex with men, and to instead screen all source plasma donors, regardless of gender or sexuality, for high-risk sexual behaviours.

On September 15, 2021 HC authorized CBS to implement behaviour-based criteria for MSM for collection of source plasma. CBS implemented behavior-based criteria at two sites (Calgary, Alberta and London, Ontario) in Fall 2021 with the intention of broader implementation at plasma sites. However, the April 28th 2022 authorization applies to plasma collection and will be implemented at all sites across the country.

On August 24, 2022, HC authorized a submission from CBS to make additional changes to deferrals. These changes include reducing the deferral for persons having taken money or drugs for sex, and their sexual partners, from a lifetime to one year. CBS is also removing a question on non-intravenous (e.g. intranasal) cocaine use and reducing the deferral period for illegal steroid use from 12 months to six months. These changes were implemented on October 16, 2022.

Monkeypox was declared a Public Health Emergency of International Concern (PHEIC) by the WHO Director-General Tedros Adhanom Ghebreyesus on July 23, 2022. The blood operators are monitoring the spread of monkeypox in Canada and will adapt as needed to ensure the safety of the blood system.

• Health Canada, as the regulator responsible for overseeing the safety of Canada’s blood system, will review submissions on a priority basis to make sure any changes are based on robust scientific evidence and maintain Canada’s high standards for safety. The safety of donor blood and plasma recipients remains Health Canada’s number one priority.
• Under Canada's Blood Regulations, the blood operators—Canadian Blood Services and Héma-Québec—are required to make submissions to Health Canada for any changes to their processes, such as changes to donor deferrals. The submissions must include scientific data that support the safety of the proposed changes.
• Health Canada is steadfast in its commitment to protecting the safety of Canada’s blood system and the recipients of donor blood and plasma. We are also committed to supporting blood and plasma donation policies in Canada that are non-discriminatory and scientifically based.