What to know about Grifols plasma collection centres and Health Canada’s safety concerns

Canada's largest for-profit plasma collector, Grifols, has temporarily paused plasma collection at all its centres nationwide after drawing increased public and regulatory scrutiny. Two deaths linked to plasma donations at Grifols facilities within the past year have intensified concerns over the company’s safety protocols. The move follows a series of reports highlighting ongoing operational and safety issues flagged by Health Canada over the past year. According to The Globe and Mail, the suspension was prompted by mounting pressure from Health Canada, which cited non-compliance with blood regulations. A senior official familiar with the situation confirmed that Health Canada issued Grifols a formal notice of non-compliance on August 12, the same day the company announced its decision to halt collection. This followed two previous letters sent in July demanding immediate action on regulatory shortcomings, which Grifols reportedly failed to address. Grifols operates 17 private plasma collection sites across six provinces, under a partnership with Canadian Blood Services since 2022. The agreement aimed to boost plasma collection to meet rising demand for plasma-derived medicines, such as immunoglobulins, used in treating conditions like immune deficiencies. Unlike Canadian Blood Services' donation centres, Grifols compensates donors for their plasma, a practice that has sparked debate over ethics and safety. Plasma collection involves a process known as plasmapheresis, where a machine separates blood into red blood cells and plasma. The red blood cells, combined with a solution like saline, are returned to the donor. A typical session lasts around an hour and removes up to 18 percent of the donor’s blood volume. Plasma replenishes faster than whole blood, allowing frequent donations, up to twice weekly, depending on individual health factors. The controversy surrounding Grifols has brought renewed focus on the ethics of paying individuals for plasma. Some argue that financial incentives could compromise safety standards, while others contend that compensation is necessary to maintain a stable supply of plasma for medical treatments. A recent article published by The Globe and Mail included interviews with individuals who had donated plasma, offering personal insights into the experience and motivations behind their decisions. Health Canada has expressed concern over the safety of plasma collection processes at Grifols facilities. Regulatory officials emphasized that the well-being of donors must take precedence over operational efficiency. In a statement, a spokesperson for Health Minister Marjorie Michel noted that the government welcomes Grifols’ decision to suspend operations and pledged continued collaboration to resolve outstanding issues before resuming activities. Grifols has defended its practices, asserting that donor safety and plasma quality have "never been compromised." The company stated that the temporary halt was a strategic step to align with Health Canada and Canadian Blood Services in developing a more sustainable and regulated plasma collection system. It also described the decision as a response to "unfounded attention," suggesting that external pressures were influencing its actions. The suspension has raised broader questions about the oversight of plasma collection in Canada. With increasing demand for plasma-based therapies, there is a pressing need to balance the expansion of collection efforts with stringent safety measures. As discussions continue between regulators and industry stakeholders, the future of plasma collection in Canada remains uncertain, pending further assessments and policy adjustments.