Blood safety in Canada

How Health Canada regulates blood and plasma

Health Canada is responsible for regulatory oversight of the safety of Canada's blood supply. As the regulator, we keep an arms-length relationship with Canada's 2 blood operators: Canadian Blood Services (CBS) and Héma-Québec (HQ). This means that Health Canada establishes, maintains and enforces regulations that the blood operators must follow.

The blood operators are responsible for ensuring that there is reliable access to safe and high quality blood, and blood products. They must submit any proposed changes to their processes and policies to Health Canada for approval.

The Blood Regulations, which came into force on October 23, 2014, fall under the Food and Drugs Act (FDA).The Regulations came out of the recommendations of the 1997 Krever Report to create separate regulations for blood and blood components.

The Blood Regulations:

set out specific requirements for blood and blood components intended for transfusion or for further manufacturing into human drugs
address blood safety (for example, determining that blood is safe for distribution) and human safety (for example, ensuring the safety of blood donors and the recipients of blood)
require that specific sections of the Canadian Standards Association Group Blood Standard be followed (CAN/CSA-Z902-15 - Blood and blood components)
- this standard addresses issues related to safety, efficacy and quality for donors, recipients and staff who collect, process, store and use human blood and blood components

Under this regulatory framework, CBS and HQ establish processes to protect the safety of blood and blood products for transfusion. They must apply to Health Canada for an authorization if they intend to make any changes to their existing processes.

Health Canada's regulatory authority for blood and blood products, the Health Products and Food Branch, reviews the evidence and the information submitted by CBS or HQ. We will authorize the processes if it's determined that the blood supply would continue to meet the high safety standards if the proposed changes are made.

The Regulatory Operations and Enforcement Branch (ROEB) monitors all health products, including blood for transfusion or for use in the manufacture of a drug. ROEB conducts industry and product investigations periodically to ensure an establishment's activities and procedures comply with both the FDA and the Regulations.

Canada's blood operators

Canada's blood operators are in charge of the blood systems for Quebec (HQ) and the rest of Canada (CBS). They manage the country's blood for transfusion system. They also purchase, import and distribute plasma products in their respective geographic areas.

Any establishment that collects blood or plasma must hold a Health Canada authorization and licence and meet the strict safety requirements of the FDA.

In Canada, both CBS and HQ:

collect, test and manufacture blood and blood products, including red blood cells, platelets and plasma
purchase plasma products from the U.S.
distribute blood and plasma products to Canadian hospitals

Plasma is the pale-yellow liquid component of blood that normally holds the blood cells in suspension. It's the starting material used to manufacture life-saving, commercial drugs known as plasma-derived products (PDPs). Thousands of people in Canada need PDPs to treat immune deficiencies, rare blood disorders and other conditions.

Most plasma products used worldwide are made from paid plasma donations and are collected by the commercial sector.

Donor deferrals

Establishments collecting blood must obtain the identity and medical and social history of a potential donor to determine their risk of transmitting an infectious disease. The blood operators set out donor screening criteria to protect the safety of blood during the donation process. They determine what type of questions are necessary to satisfy this requirement.

Based on the answers that potential donors give to the screening questions, they may be deferred from donating. There are many reasons for this, such as recent travel and certain medication use.

Deferrals can be for days, weeks or years. A person may be deferred indefinitely under certain circumstances (for example, if you have ever tested positive for Hepatitis B or C). The length of the deferral is based on what the evidence says about the risk factors and their impact on the safety of Canada's blood supply.

Because plasma can undergo additional processing steps to remove pathogens and increase safety, some people may be permitted to donate plasma, but not whole blood.

Under the Regulations, the blood operators must submit any changes to their policies, such as changes to donor screening questions, to Health Canada. Submissions must include scientific data that support the safety of the proposed changes.

We review and authorize any changes before they can be implemented. However, we only have the authority to mandate a change in extraordinary situations when there are safety issues.

Deferral for men who have sex with men

The evolution of technology and scientific evidence has supported the blood operators in making incremental changes to their donor suitability policies. The donor deferral for men who have sex with men is one such policy.

The first deferral policy was in 1984. It prohibited a man from donating blood if he had engaged in sex with another man even once since 1977.

Following submissions from the blood operators to reduce their deferral periods for this group, Health Canada authorized the following changes:

from an indeterminate to a 5-year deferral, on May 22, 2013
from 5 years to a 1-year deferral on June 16, 2016
from 1 year to a 3-month deferral on April 30, 2019

We also authorized alternative screening and collection processes at 2 CBS plasma collection sites so that a man in a monogamous relationship with another man may donate source plasma without deferral. We made this authorization on September 15, 2021.

Recent changes to screening criteria for men who have sex with men

On April 28, 2022, Health Canada authorized a submission from CBS to change its approach to blood and plasma donor screening. The 3-month donor deferral period for sexually active men who have sex with men no longer applies. As of September 11, 2022, CBS will screen all blood and plasma donors, regardless of gender or sexuality, for high-risk sexual behaviour.

Similar changes were authorized on September 6, 2022, following a submission from HQ to change its criteria for screening all blood and plasma donors. The 3-month donor deferral period for sexually active men who have sex with men no longer applies. By the end of 2022, HQ will begin screening all blood and plasma donors, regardless of gender or sexuality, for high-risk sexual behaviour.

This follows Health Canada’s approval of HQ’s submission to use sexual behaviour-based screening criteria for all source plasma donors in March 2022.

Data supporting the recent changes

This new approach by the blood operators does not pose an increased risk to the safety of Canada's blood supply.

Health Canada came to this decision by reviewing multiple sources of data and evaluating the risk against the benefits of the proposed changes by CBS and HQ. We considered the following data in our decision:

Statistical modelling to predict the possible HIV risk when using the new donor screening criteria:
- took into account current trends in HIV diagnosis, prevention, incidence, prevalence and treatment
- estimated the residual risk of HIV among blood donations with the proposed sexual behaviour-based screening criteria
  - with the deferral of 3 months, estimated HIV residual risk is 1 in 25.9 million
  - with the new deferral criteria, estimated HIV residual risk is 1 in 20.7 million (very low)
Surveillance data showed:
- the post-donation monitoring activities conducted by CBS are efficient at ensuring a safe blood supply
- there were no HIV positive donations related to newly eligible donors from the 2019 change to a 3-month deferral (from 1 year)
- when combined with the proposed high-risk behaviour criteria, CBS already includes screening questions that result in the deferral of high-risk donors
Engage study, a research-based collaborative study from Canada:
- demonstrated that a number of higher-risk sexual behaviours were correlated with recent HIV infection
- showed that adding the following 2 risk-based sexual behaviour-screening questions helped to screen out participants who had recently contracted HIV
  - In the last 3 months, have you had a new sexual partner? (if "yes", you will then be asked: "in the last 3 months, did you have anal sex?")
  - In the last 3 months, have you had more than 1 sexual partner? (if "yes", you will then be asked: "in the last 3 months, did you have anal sex?")
FAIR (For the Assessment of Individual Risk) report, conducted in the United Kingdom to identify the high-risk sexual behaviours that can lead to blood-borne sexually transmitted infections (STIs):
- demonstrated a strong link between certain high-risk sexual behaviour and higher risk of HIV and STIs (for example, increasing number of sexual partners, type of sex such as receptive or anal sex)
- recommended a more individualized risk-based donor selection policy
- helped inform the U.K.'s decision to move to a behaviour-based screening approach in June 2021 (the screening questions are similar to those proposed by CBS)
External experts provided scientific, medical and technical advice and recommendations on the proposed approach by CBS
- favoured the new behaviour-based screening criteria outlined in the submission
- had no concerns

You can find more information on our decision in our regulatory decision summary for CBS and for HQ.

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Date modified:: 2022-09-06

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