Grifols’ Canadian licence restricted after plasma donor deaths

The Ontario Health Coalition is calling on the province to restore outpatient lab testing in public hospitals following news that LifeLabs will close its Sudbury operations. Photo by FILE/POSTMEDIA

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Spanish drugmaker Grifols SA is facing restrictions on its Canadian licence to collect blood products following the deaths of two patients who made plasma donations in the country.

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Health Canada, which oversees health policy, cited “recurring, systemic deficiencies across several sites” as the reason for placing terms and conditions on Grifols’ blood establishment licence. The regulator also issued non-compliance ratings to Grifols’ Canadian head office and collection sites in Calgary and Regina, Saskatchewan.

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Two people died after giving blood plasma at Grifols collection centres in Winnipeg, Manitoba, one in October and one in January. Another patient has sued Grifols, alleging kidney damage caused by equipment failure.

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Health Canada previously told Bloomberg News that its investigation so far has not linked the plasma collection process and the fatalities. Following the deaths at the Winnipeg locations, the government “identified areas of non-compliance and requested corrective actions from Grifols,” Mark Johnson, a spokesperson for the regulator, said in a statement.

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Health Canada’s terms and conditions require Grifols to reduce the number of appointments “so staff can fully follow procedures” and “strengthen quality checks to identify and address issues quickly.” They apply to 16 plasma collection sites in the country and will remain in place until Grifols shows compliance, Johnson said.

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Grifols was unable to provide comment before publication.

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Inspections at the Calgary and Regina sites found the company failed to accurately assess donor suitability and didn’t adequately validate, calibrate, clean or maintain critical equipment. A virtual inspection of head office found it didn’t have enough people with the right education, training or experience. However, “there is no evidence that plasma safety or quality was affected,” Johnson said.

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Health Canada’s inspections are continuing.

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Canada is one of the few countries that allows payment to plasma donors.

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Mary Hughes, Grifols’ vice president of sales in Canada, was among the industry representatives who testified before lawmakers last week on the topic of Canada’s pharmaceutical sovereignty. Grifols was summoned after the plasma collection deaths were made public.

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“There is no correlation between plasma donation and death,” Hughes testified. In response to a lawmaker’s question, Hughes said people giving plasma are informed about the potential risk of death.

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Regarding the Calgary, Regina and head office inspections, “we have submitted and implemented comprehensive corrective action plans,” Hughes said. “Those findings have been remediated and we continue to cooperate fully with Health Canada.”

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Last month, Grifols announced it plans to list its U.S. biopharma unit — its main subsidiary for acquiring plasma to made into drugs. The company aims to raise as much as US$5 billion to pay down debt, Bloomberg News reported.

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With assistance from Clara Hernanz Lizarraga

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