Sandra Duvlock was 58 when she was diagnosed with dermatomyositis. The gradual inflammation of her muscles had gotten to the point where she was unable to walk, clean or feed herself. When this relatively rare disease was diagnosed, Duvlock was prescribed intravenous immunoglobulin (IVIG) treatment and long-term physical rehabilitation.
IVIG is a blood product that uses plasma proteins to boost the immune system of patients like Duvlock. Plasma is the liquid component of blood that holds red blood cells in suspension.
At 66, Duvlock’s dermatomyositis is finally under control and she is back to her daily routine with one caveat: regular IVIG treatments once a month.
Canadian Blood Services purchases plasma protein products (PPPs) like IVIG, albumin and various coagulation factors from the United States and Europe. This is because Canada uses a volunteer-only donation system and does not have the donor base to support demand. Canadian Blood Services, and its Québec counterpart Héma-Québec, are non-governmental bodies tasked with safety, procurement and distribution of blood products.
Duvlock’s IVIG costs $480 a month. The total cost over eight years of treatment is around $46,000.
Canada has seen a rise in IVIG use, with requirements going up six to eight per cent each year in the last decade. Last year alone, Canadian Blood Services and Héma-Québec purchased $670 million dollars of plasma protein products from the US and Europe, an increase from $630 million spent in 2012. Canada is the largest per capita user of IVIG in the world.
Most of the plasma protein products are purchased from countries that allow paid plasma donations. In March 2014, a new private enterprise tried to open its doors in Ontario – Canadian Plasma Resources – a for-profit clinic aimed at collecting plasma by paying donors.
While this private clinic would not have broken any existing laws, Ontario quickly drew up The Volunteer Blood Donations Act legislation (currently under review) in response. This was done to prevent the company from operating, citing safety reasons and concerns that paying donors will decrease the number of individuals who voluntarily donate blood.
Why does Canada buy plasma?
Canadians need plasma for two main purposes:
1. Transfusion, requiring 50,000 litres of donated plasma a year.
2. Manufacturing plasma protein products, requiring 1.1 million litres of plasma a year.
Canada is a volunteer blood donor only country, and collects 190,000 litres of plasma a year, more than enough to cover transfusion needs, but not enough for plasma protein products.
Canadian Blood Services sends some of the plasma collected to pharmaceutical companies to be manufactured into plasma protein products. However to meet Canadians’ needs, about 885,000 litres of plasma protein products are bought annually from US or European companies.
Canadian Plasma Resources plans to open three clinics, two in Toronto and one in Hamilton, for the sole purpose of collecting plasma for plasma protein products manufacturing.
“Before the end of the decade, we will be spending over a billion dollars a year on plasma protein products as a country,” says CEO of Canadian Plasma Resources Bazrin Bahardoust. “This money will all go outside the country.”
Why is collecting plasma so costly?
There are two ways to donate and collect plasma.
The first is whole blood donation where blood is separated into red blood cells and other products, including plasma. This is what most Canadians do when they give blood.
The second is plasmapheresis, in which blood components are separated and only the plasma is collected, while other cells recirculate back to the donor.
The advantage of plasmapheresis is that plasma can be collected more frequently and in greater quantities in one sitting. In the US, donors can donate plasma using plasmapheresis up to twice a week, compared with once every 56 days for whole blood donation.
Below is a video shot by Jerry Aulenbach while underdoing plasmapheresis. Aulenbach is a regular blood and plasma donor in Edmonton.
The disadvantage of plasmapheresis is the high cost of the machines and technology. One unit of plasma collected through whole blood donation costs $135, while plasma collected through plasmapheresis costs $719. Most of the plasma collected through Canadian Blood Services is from whole blood.
Plasmapheresis to manufacture plasma protein products has become a private enterprise.
Bahardoust, says that each plasma collection centre has to collect 30,000 to 40,000 liters of plasma annually to make the operation economically viable. Canada’s last plasmapharesis collection clinic, which recently closed in Thunder Bay, was only hitting a threshold of 15,000 litres a year.
According to Canadian Blood Services, to be able to manufacture our own plasma protein products we would need to collect 700,000 litres of plasma.
In comparison, private US clinics collect over 20 million liters a year from over 40 million donors.
With only about 3% of eligible Canadians donating blood publicly, amassing a sufficient volunteer donation base is a challenge.
“We can’t compete with the US” says Graham Sher, CEO of Canadian Blood Services. “We would need to quadruple the amount of plasma we already collect. It’s just more economical to buy it from the international market.”
Health Canada conducted a roundtable discussion on the views of Canadians about paying donors for plasma in March 2013. At this discussion, a joint presentation between Health Canada and Canadian Blood Services stated that “no country in the world [including Canada] has been able to meet their need for plasma with a solely volunteer model.”
However, in June 2013, Health Canada went on to say that “provinces and territories have the authority to allow or disallow the payment of plasma donors.”
Canada’s mixed history of blood safety
The Canadian public has had mixed reactions towards paying donors for blood products.
During the 1970s and 1980s thousands of Canadian transfusion-requiring hemophiliacs were infected with HIV and hepatitis C, in part because of plasma that was purchased and imported from high-risk prison populations in the US. This became known as The Tainted Blood Scandal.
A federal commission led by Justice Krever on the Tainted Blood Scandal found major safety gaps in Canada’s blood system at that time, and made recommendations which have shaped our current system.
Michael McCarthy, past vice-president of the Canadian Hemophilia Society and Tainted Blood Scandal victim warns in a recent Toronto Star op-ed that “we cannot be so trusting again.” He says “all it takes is a shortage of blood, a bad economic environment or new virus to trigger the next tainted blood scandal.”
However, groups like the Canadian Organization for Rare Disorders have emphatically stated the important need that plasma protein products fill for many Canadian patients.
The Ontario government stance on pay-for-plasma clinics echoes that of the 1997 Krever Commission which recommended that donors not be paid except in rare circumstances. Minister Matthew’s stated concerns are that
- Paying people for blood or plasma is a safety issue
- Compensation risks depleting the existing voluntary donor pool
- There is a risk it will exploit impoverished and low-income Canadians
Matthews has written to her counterparts in other provinces, encouraging them to introduce legislation along the lines of Ontario’s recent Voluntary Blood Donations Act.
The following sections will explore Ontario’s stated concerns.
Concern 1: Safety in volunteer versus paid donation
Kate Chipperfield, Regional Medical Leader of Transfusion Medicine at Vancouver Coastal health, says the advantage of a volunteer system is that it lends itself to more honest screening.
“The problem with paid donors is that they have an ulterior motive for donation,” says Chipperfield. “And no matter how much you test that sample for risk, it can never be as low as when you donate out of the goodness of your heart.”
She goes on to explain that testing of viruses is never perfect. “There are limitations of tests, human error, emerging new pathogens. In the 60’s, no one knew about HIV or Hepatitis B. Lowering the pre-test probability [of blood-borne infection] is one of the safeguards we have against transmission,” she says.
McCarthy agrees. “What happens when blood is purchased from populations with an increased incidence of transmittable disease, including those for which we may have no tests?”
A 2009 study found that “only one-third of injected drug users who reported selling their plasma in our study were potentially deferred as high risk donors the last time they sold their plasma.”
However, private companies that pay donors for plasma say they have an extensive screening process. “All of our donors are pre-screened,” says a spokesperson for Biolife Plasma Services, a US company. “They [donors] get annual physicals and periodic blood tests for syphilis, hepatitis and other infections. After an initial donation, their plasma is held for 60 days until it can be verified for safety.”
There is also a National Donor Registry in the US, where previously exempted donors are recorded.
Sher of Canadian Blood Services says “plasma protein products go through a different, more extensive filtering process than plasma intended for transfusion,” he says. “There hasn’t been viral transmission in plasma protein products in 25 years of using paid donors and studies have shown it is extremely safe.”
However, because Canada has not previously had a pay-for donation system, it does not have all of these safeguards in place should private plasma collection centres open.
Concern 2: Depleting the donor pool by paying people
Bahardoust agrees, arguing that the whole blood donation population is different than paid-donors. “One population donates a few times a year, minimally intrusive into a life,” he says. “But the other is going once a week. Partly to feel good and partly for their own gain; you won’t get that kind of commitment out of altruism.”
Canadian Blood Services emphasized in a 2013 report that they will be monitoring the impacts of new donor-paid facilities on the voluntary donor supply, but that given the experience of implementing parallel systems in jurisdictions in both Europe and the United States, they do not expect it to be an issue.
In fact, most countries with parallel system actually have higher volunteer donations per capita than Canada.
Concern 3: Exploiting low-income Canadians
Canadian Plasma Resources plans to pay donors $20-30 per sitting, which takes between one to two hours. This is done through either a charitable tax receipt after making a donation to the Sick Kids Foundation on behalf of the donor, or a gift card with their name. This is in keeping with the existing FDA and WHO guidelines for paid and voluntary donations.
The motivations for donors have been studied extensively and while monetary donation is important, studies show that factors like convenience and altruism are equally important.
However, McCarthy disagrees. He points out that “the location of this Toronto clinic being proposed next to a homeless shelter — it will be the homeless, the economically challenged and students who will find the $20 fee an attractive incentive…”
The evidence and the optics
Many Canadians find the idea of paying for body fluids, which is often mixed in with ideas like payment for organ donation, distasteful.
Scott Klarenbach, an Edmonton nephrologist and health economist at the University of Alberta has done extensive research looking at financial incentives for living kidney donation. He says the emotional response to paid donation isn’t consistent with established safety data.
“Some of the Krever comments in the commission are extraordinarily conservative and are from a different era,” Klarenbach says. “Risk of disease is much lower than it was in the 1990’s given the technology we now have.”
He suggests it may be time for new guidelines for blood donation. “You really need to do the research to show that it will affect safety or the existing donor pool. I am struck by the aversion to paying. If we expect people to come forward and donate out of altruism, it might be a bit naïve.”
Klarenbach goes on to say that it may be a bit hypocritical to be against paying people in Canada for plasma but then buy from those who are paid in other countries.
Canadian Blood Services says that there is no evidence that a safety issue exists, and at the end of the day, the lives of patients depend on these treatments.
“If any government in this country wants to pass a public policy saying that we shouldn’t pay citizens, that is their right but that is not my job,” says Sher. “When lives are at risk, that’s simply not an option. Our job is to worry about safety and supply.”
But McCarthy says that with $1 billion in annual funding, there has to be an effective way for Canadian Blood Services to increase the supply through volunteer donation.
Ultimately, safety concerns need to be balanced with the heavy use of plasma protein products by Canadian patients, taking into account the best current estimates of the risks of paid donation, and recognizing that donors from other countries are paid.
Is it time for a revision to current policies around paying Canadians for plasma, or should they remain the same?