Key Takeaways
- Health Canada inspected only two of Grifols’ five new Ontario plasma centres before they opened; the other three were licensed without prior inspection.
- Recent inspections uncovered training deficiencies, notably staff not knowing how to respond to alarms on donation machines.
- Two donor deaths in Winnipeg linked to Grifols clinics have prompted calls for a fresh investigation, although Health Canada says no causal link has been established.
- Under Ontario law, paying plasma donors is banned except when Canadian Blood Services (CBS) acts as an agent; Grifols operates under this exemption.
- Critics argue the province must strengthen oversight to protect donor health before relying on for‑profit plasma collection.
Background on Grifols and Plasma Collection in Canada
Grifols, a Barcelona‑headquartered biopharmaceutical firm, is the sole major commercial collector of plasma in Canada, operating 17 centres nationwide. In 2022 it partnered with Canadian Blood Services (CBS) to increase domestic plasma supply, paying donors while CBS relies on voluntary contributions. The partnership allows Grifols to act as an “agent” of CBS under Ontario legislation that otherwise prohibits payment for blood or plasma donations. This arrangement has drawn scrutiny as Grifols expands its for‑profit footprint in provinces like Ontario, where five new sites opened in 2025.
Health Canada’s Inspection Process and Findings
Health Canada’s licensing approach requires that all new blood‑collection sites be inspected within 12 months of opening, but a pre‑opening inspection is not mandatory if the operator already holds an existing licence. In early 2025 the agency conducted virtual and on‑site inspections of Grifols’ corporate office in Oakville, identifying non‑compliance in record‑keeping and staff training. As a result, Health Canada imposed licence conditions limiting the number of donors served simultaneously and mandating improved supervision. These findings echo earlier concerns about inadequate preparation for handling machine alarms during donation.
Details of the Whitby and Hamilton Inspections
Before opening, Health Canada inspected Grifols’ plasma centres in Whitby and Hamilton in early 2025. The inspections focused on operational readiness, equipment calibration, and staff competency. While no critical violations were reported that halted opening, the reviews highlighted the need for clearer emergency‑response protocols, particularly regarding alarm responses on apheresis machines. The fact that these two sites received pre‑opening checks contrasts with the status of the three later‑opened centres, raising questions about consistency in regulatory oversight.
Uninspected Sites in Cambridge, North York, Etobicoke
Grifols’ Cambridge location opened in June 2025, followed by the North York (northern Toronto) site in July 2025 and the Etobicoke (western Toronto) site in August 2025. According to Health Canada spokesperson André Gagnon, none of these three facilities received an inspection before opening, relying instead on the provision that existing licence holders are exempt from pre‑opening reviews. Nearly a year has passed since each site began operations, meaning the 12‑month window for a post‑opening inspection is either closing or has already elapsed, prompting the agency to schedule visits “in the coming weeks.”
Donor Deaths and Safety Concerns
Two donor deaths occurred at Grifols‑run clinics in Winnipeg in October 2024 and January 2025. Health Canada states it has found no direct causal link between the donations and the fatalities, but the family of one deceased donor has demanded a new investigation, citing discrepancies between the autopsy report and government records. Since 2016, Health Canada records three donor deaths linked to plasma donation, all in Winnipeg; the 2018 incident predates Grifols’ Canadian operations. The cases have intensified calls for stricter monitoring of donor health, emergency equipment readiness, and staff training on adverse‑event management.
Regulatory Framework and Licensing Exemptions
Ontario law forbids paying individuals for blood or plasma donations, yet it contains an exemption allowing CBS to compensate donors when necessary. Grifols operates within this exemption by acting as CBS’s agent, a legal construct that permits the firm to pay donors while remaining compliant with provincial statutes. Health Canada’s federal oversight governs the safety of collection practices, licensing, and adherence to Good Manufacturing Practices. The current system relies on trust that licensed operators will maintain standards without mandatory pre‑opening inspections for each new site.
Responses from Stakeholders: Grifols, CBS, Politicians
Grifols told The Globe and Mail it welcomes any forthcoming Health Canada inspections and asserts commitment to donor safety. CBS maintains that the partnership is essential to meet domestic plasma demand and reduce reliance on foreign‑sourced plasma‑derived medicines, noting it spends roughly $1 billion annually on such products. Ontario NDP MPP France Gélinas, the party’s health critic, argued that if the province grants Grifols a legal exemption, it must actively manage risks to donor health and ensure proactive regulation, warning that waiting for tragedies or widespread non‑compliance is unacceptable.
Ethical and Policy Debate Around Paid Plasma Donation
The expansion of paid plasma collection raises ethical questions about commodifying human biology and potential exploitation of financially vulnerable donors. Proponents argue that compensation increases supply, secures access to life‑saving therapies, and respects donor autonomy. Opponents contend that payment may undermine voluntary donation systems, incentivize risky behaviour, and create inequities. The debate is further complicated by the rarity of adverse events, which makes risk assessment challenging, yet the recent deaths and identified training gaps underscore the need for robust safeguards irrespective of payment models.
Future Steps and Outlook
Health Canada plans to inspect the Cambridge, North York, and Etobicoke centres in the near future, aligning with its 12‑month post‑opening inspection guideline. The outcomes will determine whether additional licence conditions or enforcement actions are required. Meanwhile, Ontario policymakers may revisit the exemption that allows paid plasma collection under the CBS agency model, weighing public‑health imperatives against ethical considerations. Continued transparency, rigorous staff training, and timely regulatory oversight will be essential to maintain public trust in Canada’s plasma‑derived medicine supply chain.