Backgrounder Paper - Plasma Donations in Canada
The issue of donating plasma for use in the production of pharmaceutical products has been the subject of recent media coverage in light of a private company - Canadian Plasma Resources - seeking to open two plasma collection facilities in downtown Toronto that would compensate donors.
The decision as to whether plasma donors can be compensated rests solely with provincial and territorial governments, and different provinces have decided to take different approaches. For example, Manitoba has allowed paid donations for over 30 years whereas Quebec has decided not to allow it.
The federal government will respect provincial and territorial jurisdiction decisions related to compensation, and citizens may wish to voice their views on the topic to their respective provincial or territorial health authorities.
The safety of Canada's blood supply is a federal responsibility that falls to Health Canada. On March 12, 2013, the Minister of Health committed to hear from Canadians on questions and views they may have about whether paid plasma donations might affect the safety of the blood supply.
The purpose of this backgrounder paper is to help explain the areas under federal jurisdiction. It provides essential facts about the stringent regulatory system in place to protect our blood and plasma products supply.
What is Plasma?
There are currently a number of questions about what plasma is, how it's used, why it's important, and the impacts paying people to donate plasma could have on our blood system as a whole.
Plasma is the yellow-coloured liquid that makes up about 55 percent of our total blood volume and has essential life-saving properties. Plasma can be obtained two ways - from a regular blood donation or by a process called "plasmapheresis" in which the liquid part of blood - a donor's plasma - is separated from the blood cells.
During plasmapheresis, a donor is hooked up to a machine that extracts the plasma and returns the blood cells to the donor, allowing donors to give plasma as often as twice a week since their red blood cells have been restored. This procedure collects double the amount of plasma than a "whole" blood donation and is much more involved, taking about two hours to complete. As a result, commercial companies generally compensate donors for their time.
Once removed, plasma can be used two ways.
It can be used as a direct transfusion to treat patients who are bleeding severely or need plasma to help their blood clot.
Plasma can also be sent to pharmaceutical companies for use in the production of drugs which are of critical importance to people around the world. For example:
- Albumin treats fluid loss in burn patients, transplant recipients, and trauma patients.
- Immune globulins treat immune disorders and severe infections.
- Clotting factors treat bleeding disorders such as Hemophilia.
This paper explains how plasma donation works in Canada, the rules that make it safe, and other key facts.
Critical Facts to Consider:
- As the federal regulator, Health Canada is responsible for ensuring that Canada's blood supply for transfusion, and the plasma used in the production of drugs, is safe.
- Choosing whether to allow payment for plasma donors is a decision under the authority of provincial and territorial governments. Payment is currently allowed in all provinces and territories with the exception of Quebec.
- Plasma is used two ways - for direct transfusions to patients and in the production of drugs called plasma products. The plasma Canadians donate for transfusions to patients is done voluntarily and will remain so. Donors are only paid for plasma when it is collected from commercial establishments for use in plasma products.
- Paying people to donate plasma in Canada is not new. It does not represent a change in policy or practice for Canada. A company in Winnipeg has been operating safely and paying donors for plasma for 30 years. Also, the plasma products we import from the U.S. are largely from paid donors.
- Paying people to donate plasma has not weakened Canada's blood system or the volunteer donor base and there is no evidence it will. This system is completely voluntary and will remain so.
- Evidence has shown that the U.S. and other countries with paid plasma donation sites have some of the highest voluntary blood donations in the world.
- The plasma collected from paid and unpaid donors is equally safe, because every donor is treated the same. Through strict regulations, screening and testing methods, and techniques to eliminate viruses, Canada has not had a single case of Hepatitis B, Hepatitis C or HIV transmitted by a plasma product in the last 25 years.
- The United States is the largest producer of plasma, with much of the world relying on its supply. About 70 percent of the immune globulins used in Canada are from the U.S., the majority of which are from paid plasma donors.
- If Canadians didn't have access to products that are currently made from plasma from paid donors, the health and lives of thousands of Canadians who rely on their life-saving properties could be at risk.
- The demand for plasma continues to grow rapidly around the world. Canada's need for immune globulins, for example, is growing at a rate of 5 to 10 percent every year. To collect this amount of plasma from voluntary Canadians donors, we'd need to increase these donations by 300 percent.
In November 2012, a commercial company - Canadian Plasma Resources - applied to Health Canada for a licence to open two plasma collection sites in downtown Toronto. Canadian Plasma Resources indicated that donors would be paid $20 per donation of plasma or they could receive a charitable donation receipt in this amount.
Health Canada consulted on this issue by hosting a Round Table Discussion on April 10th, 2013 in Toronto. Approximately 30 participants attended, including representatives from the provinces, patient advocacy groups, health organizations and individual advocates, as well as Health Canada, Canadian Blood Services and Héma-Québec. A summary report of this Round Table has been posted on Health Canada's web site along with this backgrounder.
Canada's Blood System
In Canada, two organizations - Canadian Blood Services and Héma-Québec (operating solely in Quebec) - operate and manage Canada's national blood system with the Ministers of Health of the provinces and territories serving as the corporate members. On an ongoing basis, Canadian Blood Services and Héma-Québec encourage volunteers from across the country to regularly donate blood to meet our country's needs for blood transfusions.
Canada is committed to maintaining a 100 percent voluntary, self-sufficient blood transfusion system. The only time donors are paid is when their plasma is collected by commercial companies to manufacture plasma-based drugs.
Canadian Blood Services and Héma-Québec do collect plasma from volunteer donors some of which is used in transfusion with the remainder used in the manufacturing of plasma-based drugs. Even so, this only meets a small fraction of Canada's needs for important plasma-based products such as immune globulins.
See Appendix A for more information on Canada's blood system and the roles of Canadian Blood Services, Héma-Québec, and federal, provincial and territorial governments.
Is Plasma Used in the Production of Drugs Safe when the Donor was Paid?
In the 1980s, thousands of Canadians became infected with HIV (human immunodeficiency virus) and hepatitis C through blood and plasma products - an event known as the "tainted blood scandal".
Justice Horace Krever was appointed to lead a historic inquiry into the safety of Canada's blood system. In 1997, the Krever Commission released a comprehensive report Commission of Inquiry on the Blood System in Canada with 50 recommendations to ensure a tragedy of this magnitude would never be repeated, making Canada's blood system one of the safest in the world.
Since the time of the tainted blood scandal, rigorous checks and balances have been put in place including improved screening and testing of donors, significant advancements in how plasma products are manufactured, and new techniques to eliminate viruses from plasma such as "viral inactivation". As a result, there has not been a case of HIV or hepatitis transmission from plasma products in over 25 years.
Health Canada ensures plasma and its products are safe by regulating them under the strict safety standards of the Food and Drugs Act and Regulations. Canada also works closely with the U.S. Food and Drug Administration which has equally tough regulations.
Companies collecting plasma must be licensed by Health Canada.
A company wishing to collect plasma must undergo a rigorous review of its facilities, processes, equipment, documentation, and personnel before they can receive a license. Once a company is licensed, it is subject to on-site inspections to ensure it continues to fully comply with the law and all the regulations.
Donors are carefully screened.
Before donors are allowed to donate plasma they are interviewed, must answer a detailed questionnaire, and are physically examined by health professionals for health and disease risks. All plasma donations must be tested for infectious diseases such as HIV and Hepatitis.
As an additional safety step, plasma donated by a first-time donor is never used until a successful second donation is made. This ensures the first-time donor was not in the early stage of infection and that only the plasma of repeat donors is used.
All donations are labeled and traceable and all donors must have a fixed address to donate.
Only plasma from U.S. or Canadian donors can be used in plasma products authorized for use in Canada.
This ensures that vCJD - the human form of mad cow disease - will not be introduced into our blood supply. We do not use plasma from other countries where donors may have consumed contaminated beef products.
Manufacturers are required to submit product samples to Health Canada for testing before the plasma product can be released for use in Canada.
Significant advances have been made in how plasma products are manufactured.
Plasma products distributed in Canada must be approved and licensed by Health Canada and made according to strict safety standards regardless of where the plasma comes from and whether or not the donors were paid.
During manufacturing, plasma is broken down into its individual proteins. This process is called "fractionation" and numerous steps are required to eliminate a wide range of viruses and contaminants. This process does not rely on just one type of "viral inactivation" technique but on a combination. Heat treatments, filtration, chemical cleaners, pasteurization, and acid treatments when used in combination have been extremely effective in removing viruses and contaminants. For example, one of the more recent emerging viruses, West Nile Virus, was eliminated by these standard viral inactivation steps.
Health Canada reviews the manufacturing process and conducts on-site evaluations to ensure that at least two "viral inactivation" methods have been used. Manufacturers are also required to submit product samples to Health Canada for testing before they can be released in Canada.
See Appendix B for more information on Health Canada's regulation of plasma and plasma products.
Will paying plasma donors weaken the volume or safety of Canada's voluntary blood system?
There is no evidence that paying plasma donors compromises the safety or weakens a country's volunteer blood donor system.
In the U.S., for example, where there are more than 400 paid plasma collection sites, voluntary blood donations are some of the highest in the world and continue to meet the needs of American hospitals.
Canada has seen no negative impact from the existence of Cangene Corporation in Winnipeg which has been paying donors for plasma for 30 years. Manitoba has not seen a decrease in its collection of voluntary blood donation in that province.
Germany, Austria and the U.S., which have well established paid plasma collection systems, are also amongst the world's highest collectors of voluntary blood donations, with rates nearly double those of Canada.
|Country||Blood Donation Rate per 1000 People (Volunteer)|
Health Canada takes its role very seriously of making sure that Canada's blood supply, including plasma, is safe.
A decision on whether or not to approve an application can only be made based on science and fact. Health Canada is always reviewing the latest science and, to date, has seen no evidence that paying plasma donors in Canada will have a negative impact on the safety of Canada's blood supply.
Canada already uses plasma from paid donors in the U.S. and has numerous checks and balances in place to ensure plasma and plasma products used in the country are safe.
We welcome your comments.
Additionally, if you have any science, evidence, or studies that you think Health Canada should review as part of this process, please submit them to BGTD.OPIC@hc-sc.gc.ca.
Appendix A: Canada's Blood System and Roles and Responsibilities
Canadian Blood Services & Héma-Québec
Although Canada's blood system dates back over 50 years, it underwent a major reorganization in 1998 in response to the recommendations of the Krever Commission. Canadian Blood Services was formed and incorporated as an arm's length, not-for-profit, charitable organization mandated to manage the blood supply in all provinces and territories, excluding Québec where Héma-Québec was formed with a similar mandate. The provinces and territories fund Canadian Blood Services with the exception of the province of Quebec which funds Héma-Québec.
Canadian Blood Services and Héma-Québec are responsible for all steps from the recruitment of donors through to the distribution of blood and blood components across the country. The actual transfusion and therapeutic interventions involving blood components are the responsibility of hospitals within each provincial and territorial health system. Hospitals are responsible for the quality and safety of blood transfusions.
Components of the Blood System:
- Donor recruitment
- Blood collection
- Laboratory testing
- Blood processing
- Label and release
- Inventory management
Canadian Blood Services has a two-tiered governance structure consisting of Corporate Members and the Canadian Blood Services' Board of Directors. The Corporate Members are the Ministers of Health in the provinces and territories and they, in turn, appoint the Board of Directors to oversee the organization. Each Member has identified a contact person from their Ministry to serve as the day-to-day liaison with Canadian Blood Services. These individuals are collectively referred to as the Provincial and Territorial Representatives. The mandate, roles and responsibilities for the Members and the Board are set out in a Memorandum of Understanding.
Québec's blood management system is fully integrated into the province's health-care system. Héma-Québec, the blood supplier, is in charge of recruiting donors, organizing blood donor clinics, ensuring that the products are of superior quality and providing hospitals with blood and blood products.
Québec hospitals are responsible for the quality and safety of blood transfusions. Under the authority of Québec's Minister of Health and Social Services, the Hémovigilence Committee is in charge of public health; it monitors the risks associated with blood transfusions.
In addition to their roles of managing Canada's blood for transfusion system, Canadian Blood Services and Héma-Québec are also responsible for purchasing, importing and distributing plasma products in Canada. Both organizations collect plasma that is used for transfusions. Any leftover plasma is used in the manufacturing of plasma products. However this plasma meets only a small fraction of Canada's needs. Plasma products, manufactured primarily from paid U.S. donors, make up the bulk of Canada's needs.
Role of the Federal Government
The federal government, through Health Canada, is responsible for regulating the safety of Canada's blood supply. Blood and plasma products are defined as drugs and subject to the requirements of the Food and Drugs Act and Regulations.
Health Canada's regulatory framework includes the laws, policies, standards, directives, guidelines and regulations outlining the legal requirements from collection to the distribution of blood, blood components and plasma products. Ultimately, the role of Health Canada is to ensure the safety of Canada's blood supply, including plasma, through stringent regulations and guidelines.
Role of the Provincial/Territorial Governments
The provincial and territorial governments are responsible for blood utilization and practices. They ensure that blood, blood components, and plasma products are managed by their healthcare system (e.g. used by physicians to treat patients) safely and effectively within their own province or territory, according to their provincial or territorial laws. Many provinces have a Blood Coordinating Program that works directly with the provincial regional health authorities, hospital administrators, health professionals and Canadian Blood Services (or Héma-Québec in the province of Québec).
The provincial and territorial governments have the authority to allow or disallow the payment of plasma donors. While the sale of cells, tissues and organs are banned under provincial and territorial legislation, the provinces and territories do not specifically ban paying blood and plasma donors, with Quebec being the one exception.
The Role of Private (For Profit) Organizations
In Canada, blood and its components (including plasma) that is used for transfusion is collected solely by Canadian Blood Services and Héma-Québec and only from volunteer donors. However, plasma used for the manufacturing of plasma products is also collected by private companies and from paid donors. This is not a new practice. Cangene Corporation, a private company based in Winnipeg has been licensed by Health Canada for more than 30 years and is an international supplier of plasma products manufactured from plasma obtained from paid donors.
Appendix B: The Regulation of Plasma and Plasma Products
Screening Plasma Donors
When a person presents themselves at a plasma donor clinic ready to donate their plasma, they and their plasma will undergo several levels of screening as mandated by regulations under Health Canada's Food and Drugs Act.
Plasma donor eligibility is the first level of screening. On the first visit and every subsequent visit a plasma donor must meet basic conditions of donor eligibility. A donor is not considered acceptable to donate plasma if any of the following conditions apply:
- Weight is less than 50 kg
- Temperature is greater than 37.5 degrees Celsius
- Blood Pressure is over 100 diastolic or 180 systolic
- Hemoglobin is under 125 or Hct is under 0.38
- Total Protein is under 60
- Substantial blood loss (over 200 ml) during last donation
- Prior donation of plasma or other blood component within specified period (can participate in only 1 program)
- History of medical or surgical procedures
- History of convulsions requiring treatment
- Ability to answer questions compromised by alcohol or drug use
- Prior transfusion or transplant
- Skin infection at site
- Signs or symptoms of infection
- Risk of infection with HIV, HBV or HCV based on a history of acupuncture, skin piercing, tattooing, accidental needle stick injury or occasional sexual relations with a person at risk of having these infections
- Medications that pose a risk to potential recipients
- Receipt of live, attenuated vaccine
- Animal bite requiring prophylaxis for rabies or not assessed for prophylaxis use
- Abnormal cardiovascular function or serious or chronic disease
- Abnormal respiratory function or serious or chronic disease
- Bleeding disorder
- Serious disease or medical condition of the liver, kidneys, another organ or blood system
- Persistent abnormal plasma proteins
- Current or past use of medications that poses an ongoing risk to recipient
- History of recurrent fainting associated with donation
- History, signs or symptoms of injection drug abuse
- History, signs or symptoms of AIDS or HIV infection
- Risk of HIV infection based on sexual practices
- History, signs or symptoms of chronic or persistent infection transmissible by blood
- History, signs of symptoms of Hepatitis (other than Hep A)
- Cancer, other than non-melanoma skin cancer or in-situ cervical cancer
- Risk factors for CJD or vCJD
- Positive test result for any transmissible disease agent
At the time of every donation, donors are educated about the risks involved with "plasmapheresis" (the process of extracting plasma from the rest of a donor's blood) and the entire procedure for making a plasma donation is explained. Donors are provided with educational documentation and are required to fill out a comprehensive questionnaire.
Donor screening is carried out in private and the donor should be provided with the opportunity to ask questions and to exclude themselves from donating. The comprehensive health history and lifestyle questionnaire is designed to screen prospective donors to establish that they are healthy enough to donate plasma and that their plasma will not harm a recipient.
The donor will consent to their blood being tested for blood group, antibodies and transmissible diseases and should know of no reason why their donation would not be safe for use in the manufacture of a plasma product. At their initial appointment plasma donors must also undergo a physical exam performed by a physician or trained physician substitute (eg. a registered nurse) working under the supervision of a physician.
For returning donors, the date of the last donation is checked to ensure that sufficient time has lapsed for the next donation to be given and that there is no reason for deferral or exclusion. Careful documentation and records are kept of all identification details for all donations and the final prepared plasma enabling the donation to be traced back to the donors at a later stage if needed.
To protect donor's health and safety their total blood protein levels are evaluated on every visit and plasma protein composition is tested every 4 months. Donor files are reviewed on an ongoing basis by the responsible physician every 4 months.
Collecting Plasma from Donors
The collection process includes the following safety elements: the use of a sterile collection system; proximity to hospitals for medical emergencies that may occur during donation; limits defined for plasma volume collected and the frequency of donations; the use of Health Canada approved anticoagulation solutions and saline for volume replacement; and a donor exclusion option at any time during or after the donation process (in which case any collected plasma is discarded).
Plasma collection is carried out by the process of "plasmapheresis" in a Health Canada licensed establishment where only plasma is taken from the donor. Whole blood is drawn and separated into cells and plasma by an "apheresis" machine while it is linked to the donor. The other blood components - red blood cells, white cells and platelets - are returned to the donor and the plasma is retained for use in preparing medicinal products. Because the red blood cells are returned to the donor, a plasmapheresis donor may donate more frequently than whole blood donors.
All donors are cared for both during and after the process of donation with refreshments and post-donation advice, including the ability to contact the transfusion service later if they feel that their plasma, for any reason, is not safe for use. Similar to donating blood, donors are reclined during the donation, a needle is placed into a vein in their arm and their blood is collected into sterile equipment. The equipment is used once then discarded.
It is in this sterile equipment that the plasma is separated from the red and white blood cells and platelets. These blood cells and platelets are returned to the donor through the same needle that is already in their arm. At the end of the donation, sterile saline is given through the needle to help replace the plasma that was removed. Plasma collection personnel are trained to deal with any adverse events. The monitoring of all adverse events related to plasma donation allows for the identification of actions that may be taken to reduce or eliminate problems, to improve safety for donors and the prepared plasma component.
Testing Plasma Donations
All plasma donationsundergo documented testing for Human Immunodeficiency Virus (HIV), Hepatitis B and C (HBV and HCV). Hepatitis B Surface Antigen (HBsAg), and Parvo B19 presence and a test for Syphilis are also conducted. Irregular test results are investigated and resolved before the prepared plasma is put into inventory to be distributed for further manufacturing at a fractionation or manufacturing facility. Fully automated computerized systems, equipment and quality assurance are used for the testing of transmissible diseases.
Donors who test positive for HIV, HBV or HCV are excluded from making any further donations (indefinite deferral). Other reactive cases are deferred temporarily based on federal regulations and requirements. The deferral status of the donor is indicated in a donor registry system preventing reactive donors from donating. Only plasma units that are free of transmissible disease markers, have correct physical characteristics such as color, turbidity (or cloudiness) and volume, and have proper labelling are released for distribution to a fractionation facility.
Any unit positive for a disease marker is destroyed and a look-back procedure is initiated where certain numbers of non-reactive units previously donated from the same donor, are also destroyed.
The first donation from a plasma donor will also be held in quarantine until the donor returns for a second donation. Only when the second donation has been tested satisfactorily will the donor be considered qualified. If the donor does not return, the first donation is destroyed. This enhances the added safety provided by the repeat donor, as well as serving to verify that a first time donor is not in the window phase of infection.
In addition, the usage of sterile collection and storage containers, defined labeling standards and storage requirements must be met as defined by federal regulations. Every container and label is inspected for breakage and legibility before the prepared plasma is shipped for further manufacturing to a fractionation or manufacturing facility. Labeling standards are followed in order to maintain the chain of traceability between the donor, the donation and the plasma product.
Regulating the Manufacturing of Plasma Products ("Fractionation")
Plasma is the raw material used in the manufacturing of life-saving plasma products such as clotting factors, albumin and immune globulins at a manufacturing or "fractionation" facility. The fractionation of plasma is a pharmaceutical process and is governed by legislation applicable to medicinal products rather than the legislation applicable to the collection and processing of plasma as a blood component. As such "fractionators" are regulated and have established safeguards to continue to maintain the quality of prepared plasma and the derived plasma products.
The pool of plasma used as the starting material for manufacturing plasma products consists of plasma from several plasma donations all of which are tested and must be non-reactive for transmissible diseases. Plasma units are quarantined for a minimum of 60 days upon receipt by the fractionator. Should a donor test positive for a transmissible disease on a subsequent donation during this 60 day period, the fractionator is notified and the units from that donor retrieved and destroyed.
All prepared plasma units are pooled and undergo validated viral and prion inactivation steps such as combination of solvent and detergent incubations, pasteurization (60 degrees C for 10h), low pH or acid treatments. The purified final plasma product then undergoes viral filtration and is subjected to nano-filtration, sterile filtration and/or terminal dry-heat treatments to generate plasma products of high quality and free of transmissible disease to protect recipient safety.
Throughout the entire process from the time of collection from the plasma donor, through to the manufacture of plasma products, the safety of prepared plasma and of the plasma product for recipients is protected through requirements specified in federal regulations.
Addressing Special Risk Situations
Although there are no specific regulations regarding where a plasma collection establishment must be located or not located, the regulations for plasma collection under the Food and Drugs Act are worded in a way that allows Health Canada to enforce special requirements on a case by case basis, if needed depending on the circumstances:
"An establishment must file with the Minister, a submission that contains sufficient information to enable the Minister to assess the safety of the drug and its components, taking into account the proposed operations. It is important that the blood establishment ensures that the information submitted is sufficient to enable the Minister to make this assessment."
Eliminating Transient or Higher-Risk Donors
Furthermore, the regulatory requirement for the collection establishment to be able to trace back any donation to a donor and to inform or contact the donor, as well as the reliance of plasma collection programs on repeat donors, should eliminate a transient or higher-risk donor from participating in plasma donation. These types of provisions include:
- Donation by appointment only (this is standard due to the time and complexity of plasma donation);
- Residence within a defined perimeter of the plasma collection establishment;
- The provision of a valid piece of photo identification with full name, address and signature;
- The requirement that the first donation be quarantined and destroyed if the donor does not return for a follow-up donation;
- A process to allow donors to self-exclude at any time before or after donation;
- Donor registry for all deferred donors;
- Requirement to quarantine all plasma donations for 60 days.
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