Canadian Blood Services clarifies its role in the national and international collection and use of plasma
March 13, 2013 - Recently there has been a great deal of discussion about a new collection centre in this country that will pay donors for their plasma. (Blood for sale: A new low for the Canadian blood system, Toronto Star, March 5, 2013)
Canadian Blood Services is not affiliated with this clinic, nor is it for us to determine if it should exist. As stewards of the national blood system (outside of Quebec), we wanted to shed some light on the collection and use of plasma in Canada and internationally.
Plasma is the liquid portion of blood that can be transfused into patients with a variety of clinical needs, including trauma and severe bleeding. In Canada, we collect plasma for transfusion purposes from volunteer non-remunerated (unpaid) donors who go through an extensive screening and testing process. The principle of non-remuneration for blood and plasma donors whose products are used for transfusion purposes is widely accepted internationally, and we have no intention in Canada of doing differently.
In addition to transfusions, plasma can also be further manufactured to produce specialized drugs through a process called fractionation. These products include albumin to treat burn and trauma patients; immunoglobulins for infections and immune disorders; as well as clotting factors for patients with bleeding disorders.
This plasma for fractionation is also collected by us from non-remunerated donors. Since we do not have this complex manufacturing capability in Canada, plasma for fractionation is shipped to two commercial entities, one in Europe and one in the United States. Importantly, the finished drugs are returned to Canada for patient use here.
The demand for these drugs, notably immunoglobulins, far exceeds the domestic capacity of plasma collection. We therefore purchase commercial product to supplement what’s manufactured from our plasma. It is common practice for these manufacturers to pay donors for their plasma. This situation isn’t new or unique to Canada. Most of the world’s supply of fractionated plasma products comes from paid donors.
It is important to stress that these manufacturers must be licensed by and meet stringent quality and safety standards of regulators such as Health Canada and the U.S. Food & Drug Administration. The safety procedures built into the fractionation process are extensive, and include donor screening and testing, plasma quarantine, technology that inactivates viruses and purification steps. As a result, these products are extra-ordinarily safe. Numerous studies have shown products made with plasma from paid donors are as safe as any manufactured using plasma from non-remunerated donors.
Much has been made about the fact that blood products from paid donors played a role in the tainted blood crisis in Canada, infecting many with HIV and Hepatitis C. This is true. Patients suffered irreparable harm from these products and many died as a result. But much has changed since then.
Canadian Blood Services was created in 1998 following the Krever Inquiry into the tainted blood crisis and tasked with rebuilding this country’s blood system. With the support of our funding governments, we have worked tirelessly to regain the trust and confidence of Canadians and that’s not something we would risk compromising. We’ve made transformative changes, with the safety and security of the blood supply at the forefront of every decision we make.
Part of operating a safe system is ensuring security of supply. The reality is that thousands of patients depend on these life-saving fractionated products, and without those produced using plasma from paid donors we would not be able to meet patients’ needs. Patients and patient groups understand this and have been confident in using these products without the concerns that once existed, precisely because of the extensive safety steps inherent in their manufacture.
A prohibition on paying donors for plasma would deny patients access to these products, both here in Canada and around the globe. When lives are at risk, that’s simply not an option.
Dr. Graham Sher, MB BCh, PhD Chief Executive Officer Canadian Blood Services
Click on the following links to get the perspective of a patient group that is dependent on plasma protein products.