By Wayne Schnarr
I was going to start writing about the Canadian generic drug industry when I read an article in the Globe and Mail on paid-plasma centres and their potential impact on volunteer Canadian blood supplies. In the summer of 2017, Health Canada approved the country’s third paid-plasma centre in Moncton which sparked serious debate on the ethics of offering monetary incentives to donors. While some saw this as a necessary move to boost plasma supplies in the country, the Canadian Blood Services (CBS) argued that this would put the voluntary blood donation system in Canada at risk.
The issue of paid-plasma centers is a complex one spanning ethical, safety and commercial/financial concerns. At the core of this story is the prior decision by the Ontario government to prohibit paid-plasma centres in Ontario, largely in response to The Tainted Blood Scandal of the 1980s. This article provides a high-level overview of these three areas of concern, starting with an outline of the various human blood products and their significance in the human body.
What products are derived from human blood?
Human plasma is made up of a few components however the one component that has major commercial value is plasma proteins. Plasma proteins include:
- Albumin – about 50% of the total protein in plasma, with many uses
- Immunoglobulin – the most valuable by sales (IV-IG), used to treat infections and immune disorders
- Factor VIII – to treat hemophilia A (recombinant products are approved)
- Factor IX – to treat hemophilia B (recombinant products are approved)
How safe are the products derived from human blood?
The potential concern, albeit a small safety concern, for whole blood, plasma, RBCs and platelets is that the screening may not be 100% effective in preventing donations from high-risk populations. However, the protein products derived from plasma fractionation (albumin, immunoglobulin, factor VIII and factor IX) are taken through additional safety processes namely, solvent-detergent treatment and heat treatment (pasteurization) in order to kill infectious agents.
Every donor is screened to detect potential increased risk of any of the following infectious diseases:
- Human immunodeficiency virus 1 and 2 (HIV)
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Human T-cell lymphotrophic virus I and II (HTLV)
- West Nile virus (WNV; if increased risk)
- Chagas’ Disease (if increased risk)
Who is involved in the commercial aspects of the Canadian blood system?
Canadian Blood Services (CBS) manages the collection of blood and the distribution of the varied blood products in Canada and is funded by the provincial and federal governments. The following information was obtained from their 2015-2016 annual report:
- The number of whole blood donors was 387,515
- The volume of whole blood collected in 2015-16 was 806,972 units, a decline from 879,940 units in 2013-14
- The CBS wants to triple annual plasma collection to about 600,000 to 700,000 litres from the current level of just over 200,000 litres
- About 83 per cent of the immunoglobulin that CBS distributed in Canada came from plasma obtained from U.S. donors
- 75% of the plasma needed for fractionation to meet Canadian needs is provided by U.S. fractionators
- Whole blood donors donate blood a little more than 2 times annually versus the maximum of 6 times annually (56 days between donations)
- Plasma donors donate about 9 times annually versus the maximum of 13 times (every 28 days)
Whole blood donors are needed for the transfusable components – RBCs, platelets and plasma – which are used in surgeries and emergency situations. The volume of whole blood collected needs to increase with the population growth and expanded use in specific medical situations. The number of donors needs to be expanded to handle the volume growth and any decline in the number of donors. The annual number of donations per donor appears to be relatively constant but is only at 1/3 of the allowable maximum frequency of donations.
The CBS wants to collect sufficient plasma for fractionation to meet its needs for immunoglobulin. Although the plasma will be sourced in Canada, it will still rely on U.S. fractionators. What would happen if the CBS opened its own paid-donor plasma centres across Canada? Would there be any difference in the quality of the plasma from private versus CBS centres? There would be an initial capital cost of setting up the centres but this would presumably be recouped over several years from lower Canadian plasma costs. Would the number of whole blood donors decline as they switched to being plasma donors? Would the CBS have to pay more for a whole blood donor? If the CBS paid $25 per donation for 2 million donations, that would add $500 million to the current $1 billion CBS budget which constitutes part of the $230 billion Canadian healthcare budget?
I have absolutely no concerns about the safety of the products distributed by the CBS. The blood system problems of the 1980s should never be forgotten but the screening, testing and processing improvements during the 30 years following also need to be considered. All we can hope for is an educated discussion based on science and economics rather than political expediency and election campaigns. In the next blog, I will look at the rise of the Canadian generic drug industry.
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