Curtis Brandell has witnessed the horrors of Canada’s tainted blood scandal, the country’s worst public health disaster, firsthand.
Two of his uncles suffered from hemophilia, a genetic disorder in which the blood doesn’t clot normally, and were infected with both HIV and hepatitis C from contaminated blood during the height of the crisis in the 1980s. One died. The other has been housebound for 25 years.
As someone touched by the nationwide tragedy, Brandell, who also has hemophilia, is a staunch supporter of the principles that arose from the Krever Commission, the public inquiry into the disaster that set the stage for the country’s safer, revamped national blood management system.
Among those principles: no one should be paid to donate blood or plasma, except in rare circumstances.
But that’s exactly what is happening with plasma, the yellow liquid component of blood that carries proteins, hormones and antibodies throughout the body, thanks to a recent agreement between Canadian Blood Services (CBS), the non-profit that manages Canada’s blood supply, and Grifols, a Spanish multinational pharmaceutical company. The deal — which lasts 15 years — allows plasma donors to be paid at Grifols-operated collection centres, including five in Ontario, one of which has already opened.
Currently, Ontario’s Voluntary Blood Donations Act prohibits the practice of paying donors for blood or plasma, but exempts CBS from this ban. The provincial government has given CBS and Grifols permission to open the centres with Grifols acting as an “agent” of CBS, but public blood system advocates say the legislation contains no provision for CBS to appoint another entity to act on its behalf.
Some have questioned whether allowing a private company to pay people for their plasma, even if it is acting on behalf of CBS, is even legal in Ontario.
For its part, CBS told the Star that “to be clear, Canadian Blood Services is exempt from Voluntary Blood Donations Acts. This includes exemption for any agent working on our behalf.”
Brandell, 53, says the deal has left him feeling “betrayed.” For the first 35 years of his life, he received transfusions of human-derived coagulation factor VIII, a vital clotting protein found in plasma, and worries that a pay-for-plasma model will lure people away from CBS’s valuable volunteer donor base for whole blood.
“The idea of partnering with private enterprise to pay people for their plasma and compete with voluntary donation puts our public blood system in jeopardy,” said Brandell, president of the British Columbia chapter of the Canadian Hemophilia Society.
The deal with Grifols to pay donors for their plasma has fuelled a growing debate about how closely Canada’s publicly funded blood operator should be aligning itself with private industry — and whether Ontario wants a system where paying people for a substance produced by the human body is commonplace.
CBS and others who favour the deal say it should be allowed in order to shore up Canada’s domestic plasma supply for the thousands of patients who rely on plasma-derived medications in the face of global shortages.
Others strongly oppose it, noting that paying people for their blood plasma could weaken the volunteer system and take advantage of the poor and desperate.
CBS has made one thing clear: its partnership with Grifols to open paid-plasma centres in Ontario is going ahead.
“Through the agreement, we are protecting the national system and putting important controls on where, and how much, commercial plasma is collected in the country, and bringing commercial collection in Canada into alignment with, instead of in competition with, the national not-for-profit system,” CBS told the Star. “This approach protects the blood system, addresses a global shortage of critical medications, and secures a domestic supply chain of lifesaving immunoglobulins for patients in Canada.”
On a Monday afternoon in early March, some 60 people, mostly members of the Ontario Public Service Employees Union (OPSEU), staged a protest in front of the new Grifols plasma donation centre in a Whitby strip mall. The centre, located next to an empty unit that used to be a Cash 4 You payday loan store, is the first plasma donation centre opened by the Spanish pharmaceutical company in the province.
Holding signs that read “Save our public voluntary blood system” and “Paying for blood is un-Canadian,” the protesters, including one dressed as a 10-foot-high Doug Ford puppet with fangs, had a message for the provincial government: Don’t allow paid plasma in Ontario.
The general sentiment expressed by a variety of union activists and public health-care advocates who spoke to the crowd was that paid-plasma collection not only erodes the voluntary donor base, but also exploits vulnerable people.
A study out of the University of Michigan-Ann Arbor found links between the locations of paid-plasma donation centres and high levels of poverty. Two national surveys in the U.S. cited by researchers at the University of Colorado Boulder and Washington University in St. Louis found plasma donors tended to be younger than 35, faced low employment, lacked post-secondary education and were more likely to identify as black or male.
Paying for plasma “goes against everything that the Krever Commission recommended,” Sara Labelle, chair of the hospital professionals division of OPSEU, told the protesters in Whitby, invoking the name of the Ontario Court of Appeal judge who oversaw the inquiry into the tainted blood scandal, Justice Horace Krever.
At the conclusion of the inquiry in 1997, Krever laid down five basic principles upon which the Canadian blood system should be governed. One stated that blood and plasma donors “should not be paid for their donations, except in rare circumstances.” The rationale given was that blood and plasma from unpaid donors were considered safer than blood and plasma from paid donors and that individuals who receive money in exchange for their donations “may have an incentive to donate even when they know they should not.”
The Star asked CBS for an interview for this story with its CEO, Dr. Graham Sher, but was told this could not be arranged.
CBS told the Star in an unsigned email that while Krever’s principles related to safety of blood and blood products “continue to be a guiding light,” there has been “significant change” since his report was published, noting that the country’s blood and plasma supply system has become one of the safest in the world.
“A major reason for this is the technology and manufacturing practices used to support blood-system supply chains and to create plasma-derived products like immunoglobulins have improved substantially,” CBS said. “For decades, these products have been recognized as extremely safe by regulators, the global biologics industry, blood systems worldwide and, most importantly, the patients and clinicians who use them.”
Krever also recommended that the core functions of the national blood supply system, including collection from donors, be performed by a single operator and “not be contracted out to others.”
CBS is contracting out plasma collection anyway. On its own, CBS currently operates nine voluntary plasma donation sites across the country, with two more planned.
Under the new agreement, Grifols will operate 17 paid-plasma centres, with Ontario locations slated for Hamilton, Etobicoke, North York, Cambridge and Whitby.
Not every city is on board with the plan. Hamilton and Toronto city councils last year declared their municipalities “paid-plasma-free zones,” though these are largely symbolic gestures as oversight of the blood system lies with the provincial and federal governments.
“At Grifols, we want to show that we appreciate the time, commitment and, in some cases, the expense that our donors dedicate to helping others,” says the Grifols website, which touts a “Super Hero Rewards loyalty program” offering “valuable gifts and prizes each year.”
New donors will receive “up to” $100 per donation, according to the website. The company also offers $100 bonuses for everyone who donates more than 100 times in a calendar year.
CBS told the Star the main goal of the deal with Grifols is to increase Canada’s domestic “plasma sufficiency,” the percentage of plasma collected in the country for manufacture or “fractionation” into immunoglobulins — specialized medications used to treat a variety of medical conditions, including immunodeficiencies and neurological disorders.
Canada is only 27 per cent plasma sufficient for immunoglobulins, meaning the country collects domestically just 27 per cent of the plasma it needs to make these medications. CBS purchases the remaining balance of these medications from the global market, including from Grifols. Most of the plasma used to make these products comes from the United States, where donors are paid.
CBS says it wants to bring Canada’s plasma sufficiency up to 50 per cent by incorporating collections at paid-donor centres run by Grifols, which will then fractionate this plasma into immunoglobulins in its Montreal plant. Grifols told the Star that all plasma it collects in Canada will be used to provide immunoglobulins “exclusively for CBS.”
Last year, CBS spent more than half of its $1.5 billion budget, which is funded primarily by the provinces and territories, on plasma protein- and related blood products, such as immunoglobulins.
CBS board chair Dr. Brian Postl wrote in the charity’s latest annual report that partnering with another provider to increase capacity and reach of CBS donor centres is “far more cost-effective than investing in the further expansion of our own network.”
Ontario’s auditor general has warned that the reliance on U.S. plasma drugs could put Canadians who use these products at risk if supply chains are disrupted, while a 2018 Health Canada expert panel on immunoglobulins said both paid and volunteer options for plasma donations could be considered to increase domestic supply.
CBS told the Star its agreement with Grifols, which is confidential, is “not about paid or unpaid donors,” noting that both approaches already exist and “help to supply patients the world over with essential immunoglobulins, including patients in Canada for whom we have procured safe products for decades.” (There are Grifols paid-plasma donation centres in Nova Scotia, New Brunswick, Manitoba, Saskatchewan and Alberta).
As for concerns that paid-plasma centres will erode the volunteer donor base, CBS said the agreement with Grifols has controls to limit the number of sites that the company can operate and protects against “potential negative impacts of large-scale, uncontrolled growth of the commercial plasma industry that has now been a growing reality in Canada for many years.”
For patients like Pamela Stoikopoulos, a Toronto mother of three who has a rare autoimmune condition and relies on immunoglobulin for treatment, securing a domestic supply of plasma — whether it’s paid or by donation — is her most pressing concern.
In 2017, Stoikopoulos was diagnosed with multifocal motor neuropathy, a disease that attacks the body’s peripheral motor nerves, weakening muscles in the limbs.
Since then, she has been receiving intravenous immunoglobulin, known as IVIG, twice every three weeks — treatment she says has taken her from a declining physical state back to about 90 per cent function.
“At the moment, IVIG is the only treatment option I have. It has given me my life back,” said Stoikopoulos, 53, noting that the vast majority of Canada’s immunoglobulin supply comes from the U.S., where most plasma donors are paid.
“Where is the moral outrage over this fact?” she said. “We’re already paying for plasma in Canada, it’s just coming from paid U.S. donors. I’m comfortable with the arrangement and with paying Canadian donors instead. An all-voluntary supply for plasma in Canada is entirely unrealistic.”
Peter Jaworski, a bioethicist and teaching professor at Georgetown University’s McDonough School of Business, notes that the only countries that have achieved plasma self-sufficiency are those where private industry pays donors: the U.S., Germany, Austria, Hungary and Czechia.
Global demand for immunoglobulins has been increasing at a rate of six to eight per cent annually as it is prescribed for more and more conditions, including diseases for which there are alternative treatments. This has resulted in a global shortage, a problem Jaworski says Canada should be helping to fix by increasing plasma donations using paid donors.
“Blood is local because it expires quickly, but plasma can be turned into medicines that have a much longer shelf life,” he said. “Canada is such a rich country and should be contributing to the global need for plasma.”
As for two of the main principles to come out of the Krever inquiry — that Canada should collect enough blood and plasma to satisfy domestic needs; and that no one should be paid to donate blood or plasma — Jaworski argues we can’t have it both ways.
“There’s not a single jurisdiction, not anywhere in the world, that collects enough plasma unless they pay donors.”
Back in 2014, when the Ontario Voluntary Blood Donations Act was being crafted, legislators contemplated adding a clause allowing CBS to designate an agent to act on its behalf, but the suggestion was voted down during committee hearings.
Lori Stoltz, a Toronto-based lawyer with expertise in public health law who represented people before the Krever Commission who contracted HIV through transfusion, said that begs the question: Why does CBS and the Ontario government believe the non-profit can appoint a private company to act on its behalf?
Stoltz noted there is no provision in the Ontario legislation that expressly permits the use of an agent, unlike British Columbia’s Voluntary Blood Donations Act. And even while B.C.’s Act allows CBS to appoint an entity to act on its behalf, a spokesperson for the B.C. Health Ministry told the Star the legislation “was not intended to allow a private entity to establish collection sites in B.C. with a donor remuneration model.” The spokesperson added that Grifols “isn’t planning to open any payment for donation centres in B.C.”
“What is Ontario’s argument here? The legislation is very clear in its intent,” said Stoltz, pointing to the “Purpose” section of Ontario’s Voluntary Blood Donations Act, which states that donors should not be paid, except in exceptional circumstances. “So what are those exceptional circumstances?”
When asked by the Star what the legal basis was for giving CBS permission to use Grifols as its agent to pay donors for plasma, the Ontario Health Ministry said “both CBS and its partners, operating as its agent, are required to remain in compliance with Ontario’s Voluntary Blood Donations Act.”
“Under CBS’ stewardship, the country’s blood and plasma supply system is one of the safest in the world,” the ministry said.
CBS told the Star that when the legislation was introduced, “assurances were provided that the notion of agency was implied, through the norms of legislative interpretation” by “government of Ontario officials.”
The Ontario Ministry of Health said it will “continue to monitor the decisions of Canadian Blood Services to ensure it delivers a secure supply of plasma protein and related products to Ontarians.”
In the meantime, Grifols’ rollout of paid-plasma donation centres continues.