Canada has one of the safest blood systems in the world, thanks to the strict standards set out in Health Canada's Food and Drugs Act and Regulations for the collection of blood and plasma.
In our commitment to maintain this high level of safety, Health Canada works in partnership with national and international stakeholders to actively look for any potential blood safety issues and to put into place any precautions as needed to stop the spread of infectious diseases through the blood supply.
In Canada, blood used for transfusion is collected solely by the Canadian Blood Services or by Héma-Québec and only from volunteer donors. Canadians are encouraged to donate blood regularly, if possible, as part of maintaining Canada's voluntary donation-based blood transfusion system.
Whereas, plasma used for the manufacturing of plasma products may be collected from paid donors. This is not a new practice. In fact approximately 70% of the immune globulins available in Canada are made in whole or in part from plasma from paid donors. These lifesaving products are extremely safe, due to advancements in blood manufacturing technology which now includes steps to inactivate any viruses or other contaminants. Paid plasma donors are currently critical to ensuring a sufficient supply of blood products in Canada.
Please find below are some questions and answers about plasma donation in Canada.
What is plasma and plasma donation?
Plasma is the pale-yellow liquid component of blood that normally holds the blood cells in suspension. It makes up about 55% of the total volume of an individual's blood.
Plasma donation is the process of collecting a donor's blood, separating the plasma portion of the blood from the blood cells, and then returning the blood cells to the donor. This process takes between 2 and 3 hours and is known as plasmapheresis.
What is plasma used for?
Plasma is the starting material used for the manufacturing of life-saving, commercial drugs known as plasma products.
Commonly used plasma products include albumin, which is used to treat fluid loss in burn or trauma patients; immune globulins, which are used to treat or prevent infections or immune disorders; and clotting factors, which are used for the treatment of haemophilia as well as other bleeding disorders.
Who collects plasma in Canada?
In Canada, both Canadian Blood Services and Héma-Québec collect plasma for manufacturing into plasma products. Under strict regulations enforced by the Food and Drug Act, private companies can also collect plasma for the production of essential plasma products.
Are all plasma products used in Canada made from Canadian plasma?
No. Canada is not self-sufficient for plasma products and so some products such as immune globulins need to be purchased from manufacturers that use U.S. sourced plasma. In fact about 70% of the immune globulins distributed in Canada are made from U.S. sourced plasma.
How much plasma is collected worldwide for the manufacture into plasma products and is it enough to meet global needs?
Today, about 24-26.5 million litres of plasma is collected globally each year, with the U.S. producing approximately 60% of the global supply and with 70% of the U.S. supply coming from paid donors. It is estimated that the lives of > 1,000,000 patients worldwide depend on source plasma from the U.S. obtained from paid donors.
How much of this plasma does Canadian Blood Services and Héma-Québec collect currently?
Today, Canadian Blood Services collects about 195,000 litres of plasma each year. Héma-Québec currently collects approximately 51,000 litres of plasma for manufacturing into plasma products.
Is plasma donation regulated in Canada?
Yes. The federal law that governs the collection of plasma used for making plasma products is the Food and Drugs Act and the Food and Drug Regulations. Included within these regulations are specific provisions that relate to Human Plasma Collected by Plasmapheresis.
Any establishment that collects plasma for use in making plasma products must be licensed by Health Canada. The license application must show that its donor screening and testing processes meet the strict requirements under the law. For example, before donors are accepted into a plasma donation program they must be determined to be eligible to donate. In addition to a comprehensive questionnaire and interview, donors must be physically examined for health and disease risk factors. At the time of every donation, donors are re-interviewed and their blood is tested for infectious diseases, including HIV and Hepatitis B and Hepatitis C.
Before a licence is granted, Health Canada inspects the establishment to ensure that it is meeting the safety standards set out under the Food and Drug Act. The establishment is then inspected annually to assess that it is following the law. Health Canada will take compliance and enforcement actions for establishments that are not meeting these requirements, which could result in the loss of their licence.
Furthermore, all plasma products are subjected to an additional regulatory review before they are authorized for distribution in Canada. This regulatory review includes careful examination of the plasma collection and product manufacturing processes.
Health Canada’s stringent regulatory oversight serves to complement the global standards that plasma collectors must adhere to as set by the Plasma Protein Therapeutics Association (PPTA). As part of PPTA’s International Quality Plasma Program certification criteria, plasma collection facilities must verify that prospective donors can provide proof of a fixed residential address within a set proximity to the collection center, and which is checked against a list of transient, temporary residences to exclude donors who may be part of some higher risk populations. Potential donors must also give two donations with negative disease test results before they are considered qualified and for donors who do not return for their second donation, the plasma from their first donation is destroyed. More information on the international standards for plasma donation is available on the PPTA website.
Can plasma donors be paid for their donations?
Yes. In fact, paid plasma donors are currently critical to ensuring a sufficient supply of plasma products in Canada. While neither Canadian Blood Services nor Héma-Québec pay their donors for either blood or plasma, private clinics and companies may pay plasma donors provided it is permitted by the provincial and territorial laws.
Payment for plasma donation is even more common in the U.S. Much of the U.S.-sourced plasma used for manufacturing blood products, including those that are sold in Canada, comes from paid donors. The U.S. has the same level of intense safety regulation over plasma donation as in Canada.
Many Canadians taking plasma products were infected with HIV and hepatitis during the years of the tainted blood crisis. The Krever Inquiry Report recommended that blood donors should not be paid. Isn't allowing payment for plasma increasing the risk of another tainted blood crisis?
No. Lessons of the tainted blood crisis must never be forgotten, and action has been taken since then to help prevent a tragedy like that from happening again. There are no plans to change Canada's voluntary blood for transfusion donor system. However, technological advancements have made plasma products safer. New measures such as heat treatment, filtration or treatment with chemicals have been put into place to remove or inactivate viruses or other contaminants when producing blood products from plasma. There has not been a single case of transmission of hepatitis B, hepatitis C or HIV caused by plasma products in Canada since the introduction of modern manufacturing practices over 25 years ago, despite the fact that most of the plasma donors were paid.
Canadians can be assured that establishments collecting plasma for plasma products are strictly regulated and in compliance with the Food and Drugs Act and Regulations, and that plasma products sold in Canada are manufactured in accordance with our strict safety standards, regardless of where the plasma comes from and whether or not donors were paid.
Where can I get further information on this subject of payment for plasma donations?
Canadian Blood Services has recently published information about payment for plasma donation on their website.