Plasma and the blood system supply chain
This document was originally published Oct. 27, 2021. It has been updated as of May 24, 2022, August 3, 2022, and Sept. 7, 2022.
Canadian Blood Services operates the blood and plasma supply system in all provinces and territories except Québec, which has its own similar system and blood operator. We are accountable to provincial and territorial ministers of health, who are also our corporate members, and are regulated by Health Canada.
Canadian Blood Services’ not-for-profit blood supply system has its origins in the recommendations and findings of Commission of Inquiry on the Blood System in Canada (known as the Krever Inquiry) and the related ministerial principles set out in our founding documents in 1998.
Our blood and plasma supply chain is a single, integrated system operated on behalf of provincial and territorial governments — and a vital connection between donors and recipients across the country. Over the past two decades, these characteristics have served the country well and are aligned with Canada’s smaller population and large geographic size, which both point to the necessity of a national unified system.
We have created this content to help develop a greater understanding of some aspects of what we do related to plasma and the blood system supply chain.
1. What is “blood plasma”? What is it used for? Why is it essential for patients?
Plasma, also called “blood plasma,” is the protein-rich liquid in blood that helps other blood components circulate throughout the body. It supports your immune system and helps control excessive bleeding, which is why plasma donations are important to help treat bleeding disorders, liver diseases and many types of cancer.
Plasma is a vital treatment for patients with immune deficiencies, rare blood disorders, various cancers, tetanus infections, nervous system disorders, bleeding disorders, kidney and liver diseases, severe burns, surgeries, newborns with Rh disease and much more.
Plasma has two main applications:
- It can be transfused directly into patients in hospitals; or,
- It can be manufactured into specialized medications called plasma protein products (or plasma-derived products.) Immunoglobulins, albumin and coagulating factors are examples of these products.
Globally, and in Canada, the most widely used plasma protein products are immunoglobulins. Canadian Blood Services estimates that about half of the patients in Canada who use immunoglobulins must take these drugs to live, with no other treatment available for their conditions.
2. Key terms and context related to blood and plasma sufficiency and Canada’s blood system supply chain
Our blood and plasma supply chain is a single, integrated system operated on behalf of provincial and territorial governments — and a vital connection between donors and recipients across the country.
The following terms and context are needed to build an understanding of the plasma and blood system supply chain in Canada:
- Blood: In the context of the blood supply system “blood” is an overarching term that means “whole blood and blood products, plasma and plasma products and their respective artificial and substitute products.” Since we opened our doors in 1998, Canadian Blood Services has been accountable for a “national blood supply system which assures access to a safe, secure and affordable supply of blood, blood products and their alternatives, supports their appropriate use and carries out such other functions” as designated by provincial and territorial governments.
- Whole blood: Whole blood is the unprocessed raw material Canadian Blood Services collects from donors at donor events across the country. After we collect whole blood, we process it into its different components at facilities we own and operate and then deliver these products to hospitals.
- Fresh blood products: Fresh blood products are components of whole blood used for transfusion therapies, largely in hospitals. They include products such as red blood cells, platelets and plasma, and are manufactured by Canadian Blood Services from the whole blood we collect.
- Plasma for transfusion: Plasma for transfusion can be manufactured in two ways: it can be made from plasma recovered from whole blood donations (recovered plasma) or from plasma collected using an apheresis machine (apheresis plasma). An apheresis machine separates only the plasma from the rest of the donor’s blood and then returns the remaining blood to the donor in a single closed loop at the time of donation.
- Plasma for fractionation: Fractionation refers to the process used to manufacture plasma protein products. Plasma intended for fractionation is mainly collected using an apheresis machine, although some plasma recovered from whole blood donations may also be used. Because there is a global shortage of plasma for fractionation, Canadian Blood Services, like other blood operators globally, is increasing the amount of plasma it collects to ensure the needs of patients in Canada for immunoglobulins and other plasma protein products continue to be met.
- Other related terms: Within the supply chain, various technical terms are sometimes used to describe plasma and other blood components, often referring to the collection process. Some of these include:
- Recovered plasma: This term refers to plasma produced by separating whole blood into plasma and other cellular components. Recovered plasma volumes are limited to the amount of whole blood we collect.
- Source plasma: Source plasma is collected from donors using an apheresis machine. It is used exclusively to manufacture plasma protein products through a process called fractionation.
- Apheresis plasma: This term refers to plasma collected using an apheresis machine. Apheresis plasma can be used for transfusion or for fractionation. Donation using an apheresis machine can happen more frequently than whole blood donation because the body replaces the volume of donated plasma faster than that of other donated cellular components.
- Apheresis platelets: This term refers to platelets collected using an apheresis machine. Platelet donation using an apheresis machine can also happen more frequently than whole blood donation.
- Plasma protein products: Plasma protein products are medications manufactured (or fractionated) from the proteins found in human plasma. These products have an excellent safety profile — whether they are made from the plasma of donors that have been paid or those who have not — in part because the fractionation process itself includes multiple dedicated steps of pathogen removal or inactivation. Although there are multiple categories of these plasma-derived products, three main ones are widely used in patient care:
- Immunoglobulins, which help people living with primary and secondary immunodeficiency disorders, autoimmune disorders and neurological disorders, among other medical conditions. Immunoglobulins are the most widely used category of plasma protein products.
- Albumin, which help patients with liver disease, and patients being treated for shock and serious burns among other medical conditions.
- Coagulation factors, which help those living with congenital bleeding disorders, such as hemophilia A and B and von Willebrand’s disease.
- Utilization management: This term refers to essential work across the broader blood system to identify, maintain and encourage evidence-based uses of blood products, including plasma protein and related products, to improve patient outcomes and reduce system costs. Utilization management also includes planning for potential shortages.
- Risk mitigation: As part of managing its supply chain, Canadian Blood Services engages in a range of risk mitigation activities. Examples include calling out potential supply shortages to funding governments and hospitals before they are imminent; holding an appropriate inventory of products, where possible, in light of global supply pressures; coordinating and updating national shortage plans for both blood and immunoglobulins; diversifying supply chain risk by maintaining contracts with more than one plasma fractionator and with multiple drug suppliers; monitoring the emergence of potential new pathogens that could affect safety and security of supply, etc.
Perhaps the most important risk mitigation related to plasma, however, is increasing our collections substantially to continue to meet growing demand and support hospitals and patients in the jurisdictions we serve.
- Risk-based decision-making: Blood operators are often faced with complex, evolving situations in which they must make decisions to ensure the safety and security of the blood supply for patients. In these contexts, and others, how we do things is often as important as what we do or why.
When faced with highly challenging circumstances, Canadian Blood Services uses a robust risk-based decision-making framework developed by the Alliance of Blood Operators, of which we are a member.
This framework involves environmental scanning, ethical and technical considerations, and stakeholder perspectives in its approach. It supports effective decision-making for the benefit of health systems and patients. Periodically, to reassess risk related to optimal sufficiency of immunoglobulins, we use this framework. We also apply aspects of this framework in other contexts.
In 2022, we applied this framework and engaged in a comprehensive risk analysis related to security of supply for immunoglobulins. It generated recommendations for collaborative action across the broader blood system to further ensure security of supply, including leveraging both not-for-profit and commercial sectors. Learn more about our most recent activities announced on Sept. 7, 2022.
- Integrated supply chain: On behalf of provincial and territorial governments except Quebec, Canadian Blood Services owns and operates an integrated national blood system supply chain. “Integrated,” in this context, refers to two main things:
- That the supply chain collects whole blood, plasma, and platelets under a unified plan that considers many factors, including donor population, health, marketing and relationships; geographic location of donor collection events and sites within the supply chain; best practices in keeping with a biologics manufacturer; efficiency and affordability of the blood system supply chain; etc.
- That the blood system supply chain is integrated across multiple processes and platforms — with Canadian Blood Services acting as a health system partner for governments and hospitals, as well as the system operator and expert possessing specialized capabilities. These capabilities include recruitment, collection, manufacturing, testing, and shipping products to hospitals, as well as bulk purchasing of plasma protein and other related products, utilization management, and risk mitigation practices. They also include research and development initiatives, and specialized medical and supply chain expertise.
- As we manage the many aspects of the blood system supply chain, we communicate, often daily, with our health system partners to help ensure we are meeting their needs.
3. Who can donate plasma and how often?
Any healthy person who meets the eligibility criteria can donate plasma at certain donor centres across the country. To become a plasma donor, having a history of making regular blood donations helps, but is not always necessary. Some eligibility requirements for plasma donation differ from whole blood donation, so some people who have not been able to donate blood may be able to donate plasma.
Although we extract plasma from whole blood donations, we also collect it directly from donors at our dedicated plasma donor centres and several other sites across Canada. Using an apheresis machine, we separate plasma from other blood components during the donation process. Because red cells and other blood components are returned to the donor at the time of donation, plasma-only donors can donate more frequently than whole blood donors. Plasma donors may be eligible to donate as often as once a week, compared with once every 2-3 months for whole blood donation. During each donation, they may also be able to donate as much as three times more plasma than would be contained in a single donation of whole blood.
Expanding plasma donor eligibility for gay, bisexual and other men who have sex with men: As of Sept. 27, 2021, some sexually active gay, bisexual and other men who have sex with men are eligible to donate source plasma at our Calgary, Alta. and London, Ont. centres. This is the first time Canadian Blood Services has been able to introduce questions about sexual behaviour instead of incrementally shortening the waiting period. Our goal remains to create a system that evaluates all donors equally based on sexual risk factors, and our application to Health Canada, filed in December 2021, proposed a model to do this.
In April of 2022, Health Canada approved our request to remove eligibility criteria specific to men who have sex with men and instead focus on sexual behaviour associated with higher risk of infection among all donors. When implemented this fall, this change will bring an end to men being asked during the pre-donation screening process if they’ve had sex with another man.
The new criteria will ask all blood, plasma, and platelet donors across the country, regardless of gender or sexual orientation, if they’ve had new or multiple sexual partners in the last three months. If they answer yes to either, they would be asked if they’ve had anal sex with any of these partners. If they have, they will be required to wait three months from when they last had anal sex to donate. If they have not and meet all other eligibility criteria, they will be able to donate.
We are preparing to implement the new criteria, including system and process updates, as well as robust training for employees. We plan to welcome new donors no later than Sept. 30, 2022, when the new sexual behaviour-based screening criteria are in place.
4. What is plasma sufficiency for immunoglobulins?
Canadian Blood Services is accountable for the collection and management of the supply of plasma which is manufactured into plasma-derived therapies, most notably life-saving immunoglobulins. Within this context, Canadian Blood Services is responsible for maintaining plasma sufficiency for provinces and territories across the country.
“Plasma sufficiency” refers specifically to the percentage of plasma collected in Canada by the accountable blood operator to manufacture into immunoglobulins exclusively for patients in this country. Blood supply systems around the world track plasma sufficiency with a focus on immunoglobulins because they are such a highly used category of plasma protein products.
On behalf of the provinces and territories, Canadian Blood Services ensures plasma sufficiency and security of supply for immunoglobulins by doing two things:
- We collect plasma to ship to fractionators who manufacture it on our behalf into plasma protein products for use exclusively in Canada. Once manufactured, these medications are licensed by Health Canada as biological drugs and returned to Canadian Blood Services for shipping to the hospitals and clinics we serve.
- We bulk purchase additional plasma protein products, including immunoglobulins, which are manufactured by the global biologics industry using plasma they have collected themselves. We supply these and other related products which we have also purchased on the global market, to hospitals for patients across the country.
Through these two activities, we meet 100 per cent of the need for immunoglobulins for the hospitals we serve.
Because there is currently a global shortage of plasma to make immunoglobulins, it is essential that blood systems around the world increase their plasma collections substantially. For us, this involves growing our collection activities until at least half (50–60 per cent) of the immunoglobulins patients in Canada require are made from plasma collected in this country.
This would mean that the critical needs of patients who depend on immunoglobulins to live are consistently met by Canadian Blood Services’ supply chain and controlled within Canada. We would continue to source the balance of immunoglobulins (approximately 50 per cent) needed by the hospitals and clinics we serve through bulk buying of plasma protein products from the global pharmaceutical industry.
Currently, Canadian Blood Services collects about 15 per cent of the plasma needed to make enough immunoglobulins for the hospitals and clinics we serve. It is important to understand that this does not mean patients are going without treatment. Rather, it means that we purchase about 85 per cent of the immunoglobulin required as finished products that don’t include plasma collected by Canadian Blood Services. By substantially increasing the amount of plasma we collect, we will adjust this ratio, in keeping with global supply and demand pressures.
Historically, when supply was less pressured, purchasing a greater percentage of finished plasma protein products on the global market was an affordable way to source these products. More recently, however, many factors support the need to recalibrate sufficiency levels so that more plasma is collected within Canadian Blood Services’ supply chain to manufacture into immunoglobulins for patients in Canada — including our ability to collect plasma in a much leaner, more cost-effective and scalable manner than we could in the past.
5. Plasma sufficiency and diversifying risk
Building Canada’s domestic plasma capacity within the publicly accountable blood supply system — while still maintaining contracts with specialized pharmaceutical suppliers from a variety of global sources for a portion of the products hospitals and patients need — is a strong risk mitigation strategy for the country.
In the event of a new pathogen in Canada, as was the case of the U.K. and mad cow disease (vCJD) in the 1990s, we would still have access to essential medicines manufactured by the global plasma industry that don’t include plasma collected in Canada. It is because of the U.K. experience that we do not pursue or recommend a strategy of 100 per cent self-sufficiency in plasma for immunoglobulins.
To further diversify risk, we also engage in a range of other activities. An example of these is to maintain contracts with two separate plasma fractionators (specialized pharmaceutical companies) so that should one experience conditions that negatively affect its supply chain, there is another whose services we can continue to work with.
6. Canadian Blood Services’ national formulary of plasma protein and related products
A formulary is an approved list of medications available for patients to receive. Canadian Blood Services manages a national formulary of plasma protein and related products on behalf of provincial and territorial ministries of health. “Related products,” in this context, are medications made in a laboratory from alternatives to proteins in human plasma. Whether a product is made from human plasma or an alternative, its purpose is the same: to help save, or improve the quality of, someone’s life.
In managing this formulary, we use a system-level approach that considers plasma sufficiency for immunoglobulins and long-term supply contracts with specialized pharmaceutical companies, as well as formulary and utilization management expertise. This system-level approach is an important part of our role as a health system partner to governments and hospitals across the country.
As we manage the formulary, we continue to evolve our approach with innovation and advancement in the biopharmaceutical and health-care industries. Providing clinicians with a reliable, evidence-based, and appropriate formulary of plasma protein and related products for their patients requires a highly collaborative team of experts, including clinical pharmacists, physicians, scientists, procurement specialists, supply chain professionals and leaders in stakeholder engagement. We work together to provide effective, safe, and reliable products that meet patients’ needs while optimizing value for the health-care dollars entrusted to us.
7. A global shortage of immunoglobulins
Use of immunoglobulins has been growing substantially in health systems around the world for many years. The growth has been so strong, in fact, that blood supply systems and the global commercial plasma industry are not currently able to collect enough plasma to meet demand.
In August of 2019, the American Food and Drug Administration declared a shortage of immunoglobulins. The U.S. supplies much of the world with plasma for plasma protein products, so an American shortage has serious ramifications globally.
This shortage has been made more acute by the COVID-19 pandemic, which has disrupted supply chains around the world, keeping both donors and pharmaceutical industry workers at home. As of September 2022, patients in the U.S. and Europe continued to be affected.
To date, Canadian Blood Services has been able to leverage our national supply chain and bulk buying expertise — as well as our utilization management capabilities and those of governments and hospitals across the country — so that patients in Canada needing immunoglobulin therapies have not gone without treatment.
In 2022, we engaged in a comprehensive risk analysis, which generated recommendations for collaborative action across the broader blood system to further ensure security of supply for immunoglobulins, including leveraging both not-for-profit and commercial sectors. Learn more about our most recent activities announced on Sept. 7, 2022.
8. Canadian Blood Services is collecting more plasma to meet patients’ needs
Canadian Blood Services has a mandate to manage sufficiency of immunoglobulins in jurisdictions we serve. We are working with governments to help ensure a robust domestic supply of plasma that supports patients in this country.
In recent years, three independent reports have recommended that Canadian Blood Services increase plasma collections, among other items. These include Health Canada’s expert panel on immune globulin product supply of 2018; PWC’s Collaborative Performance Review of Canadian Blood Services’ operations in 2019; and the Ontario Auditor General’s Value‑for‑Money Audit on Blood Management and Safety in 2020.
Globally, during the COVID-19 crisis, not-for-profit blood systems and commercial plasma collectors are also calling for increased plasma collections as quickly as possible to relieve the current shortage of immunoglobulins and help meet growing demand for plasma protein products.
In May of 2022, we were pleased to announce that, with funding from governments, the next new plasma donor centres will open in Abbotsford, B.C., and St. Catharines and Vaughan, Ont. by spring 2023. These new locations will build on the success of the dedicated plasma donor centres that opened in Sudbury, Ont. and Lethbridge, Alta. in 2020; Kelowna, B.C. in 2021; and in Brampton, Ont. in May 2022. An additional plasma donor centre in Ottawa, Ont., opened its doors in June 2022. More centres are in the planning stages and are targeted to launch by spring 2024, for a total of 11 centres. Through these centres, we can collect plasma in a much leaner, more cost-effective and scalable manner than we could in the past.
Discussions with the federal, provincial and territorial governments are ongoing as we work toward further increasing the plasma we collect inside our supply chain and recalibrating national sufficiency of immunoglobulins in keeping with supply and demand pressures. This is not only essential for Canadian patients, it is important on a global scale, as well. As Canada becomes less reliant on the international plasma industry, more global plasma capacity will become available to support patients around the world.
9. Commercial plasma collection in Canada
As the national blood authority, and on behalf of the provinces and territories, Canadian Blood Services is responsible for ensuring patients in Canada have access to a safe and secure supply of blood and blood products — including plasma and medications made from plasma.
Like many of our peer blood operators internationally (including Australia, the U.K. and many others), we operate a not-for-profit system. Although we don’t pay donors as commercial collectors do, we and our agents are necessarily exempt from legislation that prohibits payment in some provinces, and could do so, should a need arise.
Commercial plasma collection (where donors are paid) is a relatively new dynamic in Canada. There are a small but growing number of commercial plasma collection sites emerging in the jurisdictions we serve. A small number of commercial collection sites are not likely to have a negative effect on the national blood system supply chain. However, large-scale commercial growth — without appropriate controls — could encroach on the existing system for both blood and plasma collections.
With this context in mind, Canadian Blood Services is having ongoing dialogue with governments to determine how, as a country, we should approach commercial plasma collection with respect to sufficiency needs and to mitigate any impact on national blood system operations and our mandate to meet the needs of hospitals and patients in Canada.
This includes discussion of an end-to-end domestic supply chain for immunoglobulins, which has been a key lesson of the COVID-19 pandemic. A Canadian supply chain is needed to secure a minimum target of 50 per cent sufficiency for immunoglobulins in the quickest time possible to ensure supply for patients who have a critical need for these medications, and for which there is no other treatment. To clarify, this means we are working to reduce Canada’s dependency on the global market so that at least half of the immunoglobulins patients in Canada require will be made from plasma donated in Canada. The balance will continue to be procured through the global biologics industry, as they are today, to ensure essential diversity of supply.
This discussion follows the report of the Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada, convened by Health Canada, that encouraged governments and Canadian Blood Services to explore creative solutions to meet patients’ needs for immunoglobulins in Canada. It includes a potential role for commercial plasma collectors to contribute to national sufficiency and ensure plasma donated in Canada stays in Canada to benefit patients in this country. Dialogue with commercial vendors is necessarily part of this.
Update as of September 7, 2022: In 2022, we engaged in a comprehensive risk analysis, which generated recommendations for collaborative action across the broader blood system to further ensure security of supply for immunoglobulins, including leveraging both not-for-profit and commercial sectors. Learn more about our most recent activities announced on Sept. 7, 2022.