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 2SLGBTQIA+ 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 goal is to stop asking men if they’ve had sex with another man and instead focus on high-risk sexual behaviour among all donors. 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 some of 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, are 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 have proposed to Health Canada 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.
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 taken incremental steps to shorten the waiting period specific to men who have sex with men that dates from the tainted blood crisis.
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 a broad range of stakeholders including representatives of 2SLGBTQIA+ 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.
As we take additional steps toward greater inclusivity for donors who are gay, bisexual and other men who have sex with men, we continued 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 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.
New submission supports both safety and inclusion
In December 2021, Canadian Blood Services made a submission to Health Canada recommending a new way of screening donors – one that focuses on higher-risk sexual behaviour for all donors, regardless of their gender or sexual orientation. In making this change, we will continue to hold ourselves to a high standard of safety for the patients we serve.
We aim to be an organization that is inclusive and welcoming to all potential donors with minimal restrictions. Our proposed criteria would ask all donors about anal sex in the context of new or multiple recent partners. This would allow us to precisely and reliably identify those who may have a transfusion-transmissible infection, regardless of gender or sexual orientation.
The safety of Canada’s blood supply will always be paramount for Canadian Blood Services. We have more evidence than ever before, stemming from the MSM Research Program, international data and Canada-specific risk modelling, that indicates this change will not compromise the safety or adequacy of the blood supply. Currently the risk of HIV being introduced to the blood system is extremely low, and according to the evidence, the proposed change will not increase that risk. External scientific committees have reviewed the details of the evidence and support our conclusion that blood safety will not be compromised by our proposed approach.
Our commitment to diversity, equity and inclusion
Every day, generous donors across the country make a commitment to help save lives. Our commitment back to you — our donors, recipients, employees, stakeholders, partners, volunteers and all those who wish to join Canada’s Lifeline — is to build and support a national transfusion and transplantation system that is diverse, equitable and inclusive for all.
At Canadian Blood Services, we are continuing to take necessary steps to further evolve our practices and policies and address systemic discrimination and racism within our organization. We recognize that our future requires a significantly more diverse donor and registrant base in order to meet complex, evolving and underserved patient needs, as well as a workforce that more fully reflects Canada’s population.
We know that any work we do going forward must be intersectional in nature, examining how people’s lived experiences overlap in terms of gender identity/expression, sexual orientation, religion, ethnicity, age, visible or invisible disability, socio-economic status or any other aspect which makes them unique.
We thank all of you who have shared your experiences related to our donor screening practices. We hope that you will continue to hold us accountable for our commitments to change.
Below are examples of some of the strategic initiatives we’ve undertaken and implemented to date, to advance diversity, equity and inclusion at Canadian Blood Services.
- Establishing several employee resource groups to provide safe spaces for staff who share common identities to build a community and sense of belonging at work
- Committing to Truth and Reconciliation with Indigenous communities and individuals and undertaking work to create an informed and comprehensive Reconciliation action plan (RAP) to support positive and reciprocal relationships with First Nations, Inuit and Métis peoples.
- Undertaking work to make donor registration more inclusive for trans and non-binary donors
- Providing cultural and diversity awareness education and training to leaders and employees to help build an institutional culture of inclusive excellence
- Implementing more inclusive hiring practices and making the process for career development and advancement for existing employees more transparent and accessible
- Working to improve the ethnic diversity of our donor and registrant base so that we can more readily meet rare blood, stem cell and other specific patient needs
- Working with partners and external stakeholders to develop community-led strategies that will help us better engage with donors and provide thoughtful and inclusive outreach
- Welcoming our first chief diversity officer to advance DEI efforts across our organization
For more information about our ongoing commitments to diversity, equity and inclusion, visit blood.ca/DEI.