Plasma and the blood system supply chain
This document was updated in January 2024 and was originally published in October 2021.
Canadian Blood Services operates the blood 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 from The 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 supply chain is a single, integrated system operated on behalf of provincial and territorial governments — and a vital connection between donors and patients 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 web page to help develop a greater understanding of some aspects of what we do related to plasma and the blood system supply chain. For additional information, links to web pages where you can learn more have been provided, and you can click on words or terms in bold red font for their definition. A complete glossary of these terms is also available at the bottom of the page.
- What is plasma? What is it used for? Why is it essential for patients?
- What are plasma protein products?
- Canadian Blood Services’ national formulary of plasma protein and related products
- Canada’s plasma supply and diversifying risk
- What is plasma sufficiency for immunoglobulins?
- A global shortage of immunoglobulins
- What is the impact of continued supply pressures on Canada?
- Canadian Blood Services is collecting more plasma to meet patients’ needs
- Commercial plasma collection in Canada
1. What is 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 is used to make vital medical treatments for patients with immunodeficiencies, rare blood disorders, cancers, neurological disorders, bleeding disorders, kidney and liver diseases, severe burns, surgeries, newborns with Rh disease and many other life-threatening and chronic conditions.
Plasma has two main applications. It can be:
- Transfused directly into patients in hospitals
- Manufactured into various lifesaving medications called plasma protein products (or plasma-derived products.)
2. What are 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 to remove or inactivate pathogens. Although there are multiple categories of these plasma-derived products, three main ones are common in patient care:
- Immunoglobulins, which help people living with primary and secondary immunodeficiency disorders, autoimmune disorders and neurological disorders, among other medical conditions.
- 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.
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.
Read more about plasma protein products and watch a video about how they’re made here.
3. Canadian Blood Services’ national formulary of plasma protein and related products
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.
4. Canada’s plasma supply and diversifying risk
Ensuring Canada has an appropriate domestic plasma supply for transfusion and to manufacture medications 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.
5. 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 lifesaving 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 and managed by the accountable national blood operator, Canadian Blood Services, to manufacture 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.
6. 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 were not 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.
The shortage was intensified by the COVID-19 pandemic, which disrupted supply chains around the world, keeping both donors and pharmaceutical industry workers at home. Post pandemic, patients globally continue to be affected by supply pressures for immunoglobulins.
7. What is the impact of continued supply pressures on Canada?
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.
However, because of the 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 17 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 83 per cent of the immunoglobulins 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 acceptable 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.
In 2022, we applied the Alliance of Blood Operators' risk-based decision-making framework recommendations for collaborative action across the broader blood system to further ensure the security of the domestic supply of immunoglobulins for patients in Canada. Learn more about the recommendations from the analysis and how we’re acting on all of them here.
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, it has been recommended that Canadian Blood Services increase plasma collections and Canada’s sufficiency rate (e.g. Health Canada’s expert panel on immune globulin product supply of 2018). Globally, during the COVID-19 crisis, not-for-profit blood systems and commercial plasma collectors also called for increased plasma collections as quickly as possible to relieve the shortage of immunoglobulins and help meet growing demand for plasma protein products.
Since 2020, with support and funding from federal, provincial and territorial governments, Canadian Blood Services has opened nine plasma donor centres, located in Kelowna and Abbotsford, B.C; Lethbridge, Alta.; and Brampton, Ottawa, St. Catharines, Sudbury, Vaughan and Windsor, Ont. In addition, two more centres are in the planning stages and will bring the total to 11 Canadian Blood Services’ donor centres dedicated to collecting more plasma in Canada. 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 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
Historically, commercial plasma collection in Canada (where donors are paid) happened only at one highly specialized site operating in Winnipeg, Manitoba. With demand for medications made from human plasma on the rise, however, more commercial collection centres have opened in some jurisdictions where payment for plasma donation is allowed.
Canadian Blood Services has always said that 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 have negative impacts on the existing system for both blood and plasma collection and threaten our ability to meet patient need.
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.
In 2022, in response to growing supply pressures made more urgent by the pandemic, we engaged in a comprehensive risk analysis on sufficiency and security of supply of immunoglobulins. The analysis generated recommendations for collaborative action across the broader blood system, including leveraging both not-for-profit and commercial sectors to further ensure security of supply. Learn more about our most recent activities announced on Sept. 7, 2022, including:
- our agreement permitting Grifols, a global plasma industry leader, to collect a limited amount of plasma in Canada on our behalf — while ensuring appropriate protections for the national system, and
- related actions to establish the country’s first end-to-end domestic supply chain for immunoglobulins, which has been a key lesson of the COVID-19 pandemic.
More information on the steps Grifols is taking to fulfill their contractual commitment to Canadian Blood Services can be found here.
Outside of this agreement, Canadian Blood Services continues to have ongoing dialogue with governments to assess how, as a country, we should approach commercial plasma collection with respect to sufficiency needs and to mitigate impacts on national blood system operations and our mandate to meet the needs of hospitals and patients in Canada.
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.
Glossary of key terms related to plasma and Canada’s blood system supply chain
The following is a complete alphabetized list of terms and definitions that are populated throughout the information above.
A process used to isolate and collect specific blood components from a donor. Blood components are separated by a specialized machine so that only plasma and/or platelets are collected. The rest of the blood is returned to the donor in a single closed loop as they donate.
We collect both plasma for transfusion and plasma for fractionation by apheresis.
Because the body’s plasma supply replenishes within days, plasma donors can give more plasma per donation and can donate much more frequently than whole blood donors. Canadian Blood Services has chosen to collect plasma every six days; however, Health Canada has approved an interval of every three days for plasma donation in Canada.
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”.
An approved list of medications that are available for patient care through a program or plan managed by a licensed provider. Canadian Blood Services manages a national formulary of plasma protein and related products.
The process used to manufacture medications from plasma. During this process, plasma is separated (or fractionated) into the proteins found in plasma. Different proteins make a range of medications, such as immunoglobulins.
Fresh blood products
The components of whole blood which have been processed for use as transfusion therapies, largely in hospitals. These products include red blood cells, platelets and plasma.
Canadian Blood Services collects and manufactures fresh blood products at facilities we own and operate for use by health-care centres and patients in Canada.
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:
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.
Plasma for fractionation
Plasma that will be used to manufacture various medications, which are collectively called plasma protein products. Plasma used to make medications is often called “source plasma” within the biologics industry.
Plasma for transfusion
Plasma that Canadian Blood Services processes for use in transfusion therapies (directly administered to a patient through intravenous methods) in health-care centres across the country.
Plasma for transfusion is often used in urgent care for conditions such as liver failure, severe infection and excessive bleeding.
Plasma protein products
Lifesaving medications which are manufactured from proteins which can only be found in human plasma. Different proteins make a range of medications which are used to treat patients in Canada with a growing list of rare, life-threatening and chronic medical conditions.
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.
As part of managing Canada’s blood system supply chain, Canadian Blood Services engages in a range of risk mitigation activities, which 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.
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.
The unprocessed raw material collected from blood donors. After collection, we process whole blood into its different components, which are red blood cells, white blood cells, plasma and platelets. Plasma collected by whole blood donation is called “recovered plasma”.
Because red blood cells take several weeks to replenish, we collect whole blood from donors every 2–3 months.