Two donors have died in recent months after giving plasma at Grifols’ clinics in Winnipeg, one in October and one in January.Shannon VanRaes/The Globe and Mail
Conservatives are calling on Health Canada to improve its oversight of plasma collection centres run by Spanish company Grifols after the deaths of two donors and a federal inspection report that suggests the regulator uncovered deficiencies at some clinics that persisted for years.
Grifols is Canada’s only major commercial collector of plasma, a protein-rich, golden-coloured fluid found in blood that is manufactured into high-demand medicines, primarily for patients with immune deficiencies.
Grifols has 17 sites across the country and operates as part of an agreement signed with Canadian Blood Services in 2022. The company pays donors, while CBS does not. CBS, a government-funded charity, spends $1-billion annually procuring plasma-derived medicines, including from Grifols, which it distributes to hospitals in a pharmacare-like program.
Two donors have died in recent months after giving plasma at Grifols’ clinics in Winnipeg, one in October and one in January. The Globe and Mail reported this week that a federal inspector later wrote a report on the Grifols location visited by the donor who died in October, on Taylor Avenue. The report flagged multiple deficiencies at the site, including concerns about whether staff knew how to respond properly to alarms sounding on donation machines.
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However, Health Canada said last month that it had found “no linkage” between the deaths in Winnipeg and the plasma donation process.
Other Grifols locations, in Calgary and Regina, were given non-compliant licence ratings during Health Canada inspections in December and January. They remain open, as do the Winnipeg locations.
Despite the non-compliance across several Grifols clinics, Health Canada did not make any concerns public until after media reports revealed the deaths in March. On April 1, the regulator imposed conditions on Grifols’ licences, ordering the company to reduce the number of appointments per hour, better supervise new staff and improve donor records.
Conservative MP Dan Mazier, who has reviewed the Health Canada inspector’s report written after the Winnipeg death in October, said he was struck by what appeared to be a lack of repercussions for the company and poor follow-through from the government.
“There’s been zero follow-up from this health minister on this, and from Health Canada as well, so that’s very concerning, and I think that needs to be uncovered,” said Mr. Mazier, who is the party’s health critic.
He said it is important for the government to enforce regulations to uphold Canadians’ trust in the health care system. “You’re putting the health and safety of Canadians at risk,” he said.
Internal government documents obtained by The Globe under access-to-information law, the contents of which have not been previously reported, show some public servants were alarmed after the second death, at the end of January.
That death, on Jan. 30 after a donation at Grifols’ Innovation Drive location in Winnipeg, was reported by Grifols to Health Canada on Feb. 3, and triggered a visit by Health Canada inspectors on Feb. 9 and 10.
On Feb. 11, a senior Health Canada official e-mailed her counterparts at the health ministries in Manitoba and Nova Scotia with an urgent request to meet.
“I am reaching out on behalf of Health Canada to discuss a recurring issue that we have noted regarding plasma donations in Manitoba,” wrote Christine Leckie, director general at Health Canada’s medical devices and clinical compliance directorate, in an e-mail.
Health Canada found multiple issues at Grifols’ Winnipeg clinic after death, inspector report shows
She asked if they could “mobilize our respective teams to work together going forward to mitigate any immediate health risks.”
The e-mails do not describe the result of that meeting, although further e-mail chains show the deaths were on the agenda of a meeting of provincial representatives of the Canadian blood liaison committee on March 12.
Alexandre Bergeron, a spokesperson for Health Minister Marjorie Michel, said the government takes the health of donors seriously.
“Following reports concerning Grifols’ plasma collection centres, Health Canada conducted inspections and imposed strict conditions on the company to ensure compliance with Canada’s blood safety regulations,” she said in an e-mail. “Those conditions will remain in place until Grifols shows ‘sustained compliance’ with blood regulations at all licensed sites.”
Deaths from plasma donation are very rare. Health Canada has said it has records of three deaths that are connected to plasma donation in the past 10 years, including the ones in October and January, and all of the deaths occurred in Winnipeg.
Grifols told The Globe in response to questions about the inspector’s report that it has submitted detailed action plans to Health Canada, which it said it began implementing immediately, and will work closely with the regulator to meet its licence requirements.
The company also increased its pay for donors in Canada as of May 18, according to its website.
Amounts vary depending on the volume of plasma collected and number of visits a donor has made. The new schedule shows payments of $100 at the high end for the first four visits at the maximum volume. The company rewards clients who donate more than once in a week with higher payments, and also offers bonuses to recurring donors who hit various milestones. The lowest amount on the new schedule is $40, higher than $30 previously.