Grifols, a prominent player in the plasma collection industry, operates 17 paid plasma donation clinics across Canada, including two locations in Toronto. Literally days ago, Health Canada performed an inspection and cited Grifols’ operating procedures for “serious deficiencies.” That not only raised questions about the need and accessibility of their facilities. The inspection further discovered rules violations involving accident investigation procedures and rulemaking procedures.
In the last three and a half years, Health Canada inspectors have found Grifols to be noncompliant on four separate occasions. The most recent inspection at the company’s Oakville, Ont. facility found failures in quality control and raw ingredient processing procedures. At the Regina site, Grifols processed a donor’s germinal plasma twice within 48 hours. This move was against federal law, according to reports.
Grifols has an Agency model where they are agents for Canadian Blood Services (CBS) in Ontario. In order to attract new clients, the company extensively utilizes social media advertising. Clinical donors at Grifols clinics are compensated on a sliding scale, with additional bonuses for more regular donations. All these practices implemented, one would assume, but just recently alarm bells went off. Two men died soon after donating plasma at Grifols’ clinics in Winnipeg, raising alarm bells from health care advocates.
“Why are there no consequences for Grifols for repeated non-compliance across the country?” questioned Natalie Mehra, executive director of the Ontario Health Coalition. She said she was shocked that Grifols wouldn’t be held accountable given its long track record of violations.
Critics say that Grifols has had immunity to continue expanding even as the same problems have continued. “It’s like they’ve been given an open checkbook to grow,” said Mehra, warning of the dire need for regulatory standards.
Matt Strauss, a member of the Canadian Parliament, expressed his dismay over the U.S. practice of paying for blood plasma donations. He stated, “This is just outrageous, and my constituents are really concerned about any payment for blood, plasma or tissue donation. He voiced concerns over the potential risks involved, noting that the situation could indicate either “astoundingly statistically improbable — or something quite medically incorrect has occurred.”
In response to the recent incidents and inspection findings, Grifols has maintained that it sees “no reason to believe that there is a correlation between the donors’ passing and plasma donation.” In a written statement, a spokesperson pointed to their vigorous commitment to donor safety and plasma quality. They claimed that Health Canada’s inspection framework actually fosters their pursuit of continuous improvement.
In July, Grifols was invited to testify in front of the House of Commons’ Standing Committee on Health. Yet they decided to do the obvious and tackle the urgent issues head-on.
