Evolving eligibility criteria for gay, bisexual and other men who have sex with men
Our purpose
Canadian Blood Services operates Canada’s blood system in all provinces and territories except Quebec, which has a similar system managed by Héma-Québec. Most of our funding comes from the provincial and territorial ministers of health, who act as corporate members. Health Canada regulates Canada’s blood operators.
Canadian Blood Services is an essential health system partner to hospitals and the patients they serve across the country. Our role is to provide lifesaving products and services in transfusion and transplantation for patients and to safeguard Canada’s systems of life essentials in blood, plasma, stem cells, organs and tissues.
We collect blood, plasma and platelets from non-remunerated donors and manufacture them into blood products. We then ship these transfusion products to hospital blood banks on behalf of the provinces and territories.
We also collect plasma and work with pharmaceutical suppliers to “fractionate” or process the plasma on our behalf into drugs called plasma protein and related products (PPRP). They then return the PPRP to Canadian Blood Services, and we ship these products to Canadian hospitals and clinics for exclusive use by patients in Canada.
Our background
Canadian Blood Services was founded in 1998 following Justice Horace Krever’s public inquiry into the contaminated blood crisis.
The inquiry examined a devastating failure of public health systems, resulting over time in approximately 2,000 HIV and 30,000 hepatitis C infections. Thousands of people died and trust in Canada’s blood system was lost.
In response to this crisis, and in accordance with Justice Krever’s recommendations, governments created two independent blood authorities: Canadian Blood Services and Héma-Québec. These organizations were charged with rebuilding and maintaining a safe, secure, affordable blood system serving patients and hospitals across the country. The painful lessons of that time, and Justice Krever’s focus on patient safety, continue to inform what we do today, including our approach to blood donor screening.
Safeguarding the blood supply
In Canada, blood donor eligibility criteria are developed within a strict, evidence-informed regulatory framework that focuses on patient safety, which includes blood product quality and efficacy.
As the system regulator, Health Canada is responsible for reviewing and approving blood operators’ requests for changes to processes including donor selection.
As a blood operator, Canadian Blood Services is responsible for gathering sufficient evidence to make a request for change to Health Canada. Our changes are informed by the available science and the frequency and pattern of health events in a population (epidemiology). The process also includes extensive stakeholder consultation.
Health Canada alone has the authority to approve changes to donor selection criteria that impact human safety or the safety of blood. For Canadian Blood Services to apply to make a change, we must be able to provide evidence that the proposed change will not compromise safety.
A submission to change screening criteria may include:
- A demonstration there is no substantive risk increase due to the proposed change for both known and emerging pathogens.
- An analysis of the impact on emerging pathogens.
- A review of international practices including the impact to product safety
- A summary of consultations with high-interest stakeholder groups such as:
- Patient groups who receive frequent transfusions
- Key stakeholders such as people from LGBTQ2+ communities and organizations
- Other community groups interested in expanding eligibility for blood donation
- A blood operator plan for monitoring product safety after the changes are introduced
Blood donor screening: a multi-layered safety process
To achieve the highest level of safety, Canadian Blood Services uses a standardized questionnaire to screen potential donors, as well as blood tests on each donation. Layering donor screening with blood testing has been successful to ensure the blood supply in Canada is safe and sustainable. This approach is used by blood systems internationally.
Donor eligibility criteria help reduce risk of bloodborne pathogens in two ways. Firstly, blood tests exist only for select pathogens (for example hepatitis C, hepatitis B, Chagas disease, West Nile virus and HIV). Hence, for emerging pathogens and for those that cannot be identified by testing, screening questions minimize the risk of transmission.
Secondly, even with pathogens for which there is a test, there is a window period between when a person is infected and when the test can detect the infection. The donor eligibility questionnaire helps reduce the risk of missing infections in the window period.
Many individuals who complete the eligibility questionnaire may be ineligible to donate blood, either on a short-term or permanent basis. Someone who has a fever or a flu or who has had a recent minor surgical procedure may be excluded for a short period of time, while someone who has a history of certain cancers can be excluded permanently. These exclusions exist to ensure that blood donations do not harm recipients.
While the window period for HIV is approximately nine days, the window period for other viruses, such as hepatitis, is much longer. In the time-based deferral approach, there are also some individuals who have a shorter or longer window period. For safety and simplicity, the deferral period is based on the longest window period.
Donors’ experiences matter: Although our operations are built around patient safety, the experiences of our donors matter deeply to us. Through their generosity, blood and plasma donors provide the essential biological material that allows Canadian Blood Services to create medical therapies that patients rely on. We understand that what we say, what we do, and how we do it must inspire people of all ages and from all walks of life to continue to be a part of Canada’s Lifeline. Our commitment to donors is stated on our website. It is informed by this understanding and by our commitment to patient safety.
We truly understand that being turned away from donating blood can leave donors with a sense of frustration and disappointment. We recognize that eligibility criteria for men who have sex with men is a particularly sensitive issue affecting many who have experienced longstanding marginalization and stigma. We also recognize that the incremental changes to donor criteria that still exclude many gay, bisexual and other men who have sex with men have been painful and frustrating for many, and we aim to create a more inclusive system.
Our end goal is to remove questions about men who have sex with men. We are working diligently toward greater inclusivity for donors while maintaining a safe and adequate supply of blood products for the patients we serve. This will be partially achieved by asking all donors about sexual behaviours.
We acknowledge that our donor health questions currently and in the past have disproportionately impacted racialized Canadians due to our geography-based policies. As the patterns of disease and our testing platforms evolve, we commit to reviewing and updating our safety procedures.
Our current criteria, which impact gay, bisexual and other men who have sex with men, is based on a broad statistical picture of risk rather than individual risk assessments.
According to data collected by the Public Health Agency of Canada (PHAC), the incidence of HIV and hepatitis C is substantially higher in Canada among men who have sex with men than it is in the rest of the population. According to PHAC, men who have sex with men represent three to four per cent of the Canadian adult male population, but about 40 per cent of all HIV cases in Canada, and 50 per cent of all new HIV infections.
We understand, however, that individuals within a group are not all the same. This is part of the reason why we are working towards a new way of screening donors that looks at the risks of specific sexual behaviours.
Blood safety considerations in Canada and around the world
Canada has one of the safest blood systems in the world. Since Canadian Blood Services began managing Canada’s blood system in 1998, there has not been a single transfusion-transmitted blood-borne infection from either hepatitis C or HIV.
Despite a multi-tiered safety system, however, there isn’t a way to anticipate new pathogens or other unknown risks to the blood system. As new data and evidence are collected, they become part of a body of research used to inform recommendations and decisions about the eligibility criteria, collection methods, equipment used, storage, transportation and all else in between.
No international consensus: Because the patterns, causes and effects of bloodborne pathogens such as HIV differ by country, there is no international scientific consensus among blood system operators related to donor criteria for men who have sex with men.
Although some blood centres in Spain and Italy ask about safe sex practices or monogamy, in those countries physicians interview individual donors and may be able to perform individual health assessments. It should also be noted that the rate of donors with HIV-positive test results in these countries is more than 10 times higher than in Canada.
The U.K. has implemented a sexual behaviour-based screening for all donors effective June 14, 2021. Canadian Blood Services is on the same journey.
Evolving blood donor eligibility
Canadian Blood Services’ commitment to a more inclusive approach to donor screening for gay, bisexual and other men who have sex with men dates back many years. Since 2013, we have been taking incremental steps to change and, ultimately, remove a time-based criterion for men who have sex with men.
This policy has required a waiting period between the donor’s last sexual contact and the time of donation. The current three-month waiting period is the final iteration of the time-based policy.
As we made these changes, we consulted with stakeholders through a working group which includes representatives of LGBTQ+ communities and the patient groups served by the blood system. The intent of these ongoing consultations is to understand all perspectives more fully and to make incremental change that is understood by key stakeholders.
Going forward, as we take additional steps toward greater inclusivity for donors who are gay, bisexual and other men who have sex with men, we will continue to engage meaningfully with these stakeholders, listening to their views and seeking their input on potential solutions.
Progressing plasma donor eligibility
In September 2021, Health Canada approved our submission to enable some gay, bisexual and other men who have sex with men to donate source plasma (plasma that is used to manufacture into plasma protein and related products) beginning at donor centres in Calgary, Alta. and London, Ont. in Fall 2021. Male source plasma donors who answer yes to having had sex with a man in the last three months are eligible to donate if they are in an exclusive relationship with one partner and and meet all other eligibility criteria. This is the first time that Canadian Blood Services has had the evidence and support needed to seek regulatory approval to use screening questions that focus on high-risk activities for men who have sex with men.
Why source plasma and not whole blood? Source plasma is used to make medications. The manufacturing process for these medications involves complex steps that are applied to a large pool of plasma donations, and in this process potential pathogens in the plasma are eliminated. This added safety process and our ability to freeze and hold plasma for up to a year makes it possible to expand plasma donation eligibility sooner.
What is source plasma? Plasma is the straw-coloured, protein-rich component in blood that supports your immune system. It also helps control excessive bleeding and can be used to help treat bleeding disorders and cancers. Specialized medicines made from plasma proteins help treat a variety of rare and genetic, life-threatening conditions. The plasma that is collected to be made into these medications is referred to as 'source plasma'. Source plasma is collected through a donation process called apheresis. Apheresis donations allow blood operators to separate and collect only the donor’s plasma. Since the red blood cells are returned to the donor’s body, donors can give plasma much more frequently than whole blood.
Globally, the demand for medicines made from plasma proteins has been rising quickly. Usage for a main category of plasma protein and related products — immunoglobulins — has more than doubled internationally over the past 10 years. Immunoglobulins are used to treat primary and secondary immune deficiency disorders, autoimmune disorders, neurological disorders and other diseases with an immune origin. Collecting more plasma will help thousands of patients in Canada who depend on these therapies. Canadian Blood Services is responsible for ensuring a safe and secure supply of plasma and we rely on the generosity of volunteer donors to do so.
Continuing to pursue expansion of whole blood donation
In order to move to a behaviour-based screening model that is right for Canada, Canadian Blood Services, in partnership with Héma-Québec and with funding from Health Canada, is supporting 19 independent research projects investigating various aspects of blood and plasma donors’ eligibility criteria and screening process. Some projects are already completed or will be completed in the coming months and will help inform our next submission to Health Canada’s regulatory branch to further evolve blood donor eligibility criteria. Research themes include the development of individual risk assessment donor policies; the assessment of operational feasibility and acceptability; and the assessment of risk of proposed policies, among other areas.
Canadian Blood Services is also engaged in modelling to assess the best method for Canada to move forward with more change.
The time-based deferrals in place so far have been extremely safe, but also limiting because they defer all sexually active men who have sex with men. In sum, we are laying the groundwork for the next step forward.
Over the coming months, the evidence and analyses will inform discussions with Health Canada and ultimately provide the basis for our submission to the regulator to move to a behaviour-based screening model for all donors.
Our goal is to make a submission to Health Canada by the end of 2021. Our submission will recommend removal of the current criteria for men who have sex with men across all collection types, and instead ask all donors about sexual behaviours. In making this change, we will continue to hold ourselves to a high standard of safety for the patients we serve.
Our commitment to diversity, equity and inclusion
We are grateful to donors and prospective donors of all ages and backgrounds who support Canada’s Lifeline. Whether you donate blood, plasma, stem cells, organs or tissues, or you are a financial donor, we recognize and value your generosity and your continued support as we change the system safely. We are committed to continuing to work together in creating the best possible blood system for all who depend on it.
We acknowledge that health care organizations have long played a role in reinforcing inequity and systemic racism in Canada. These things exist within our own organization, and we know that any work we do going forward must be intersectional in nature, examining how people’s experiences overlap in terms of gender, sexuality, racialization, class, ability and other important factors.
We thank all of you who have shared your experiences related to our blood donor screening practices. We understand that, organizationally and operationally, we are not immune to discrimination in health systems and settings. To date, some of the key activities related to our diversity, equity and inclusion program include:
- Posting a public statement of commitment on our website.
- Providing education and training resources to our teams to raise awareness of this critical area at all levels of our organization.
- Completing process and policy reviews, including recruitment, onboarding and performance management processes.
- Creating employee resource groups to nurture a working environment where everyone feels accepted and supported in a meaningful way.
- Engaging an external consultant to conduct a diversity, equity and inclusion assessment, completed in July 2020.
- Enrolling in the Government of Canada’s 50-30 challenge. The goal of the program is to challenge Canadian organizations to increase the representation and inclusion of diverse groups within their workplace, while highlighting the benefits of giving all Canadians a seat at the table.
We have invited the public to hold us to account and will continue to work with those who bring concerns forward. We owe it to all who call Canada home to be as inclusive as possible while maintaining a safe, effective and affordable system.
We are committed to being part of the solution.