A U.K. drug marketing watchdog has slammed CSL Seqirus for “multiple and prolonged deficiencies” in its systems, governance and oversight.
The PMCPA, a self-regulatory body in the U.K., began investigating CSL Seqirus after the flu vaccine manufacturer voluntarily admitted problems with the disclosure of payments. CSL Seqirus failed to disclose two grants to a French healthcare organization. The company named an intermediary, rather than the ultimate recipient, as the beneficiary of a third payment.
“Payments totalling an excess of 700,000 pounds ($925,000) had been made to a healthcare organization without the required documentation or public disclosure,” the PMCPA said in its report. “CSL Seqirus had only become aware of the issue following a grant application from the same healthcare organization in 2025.”
The company rejected the 2025 grant application, leading it to investigate the earlier payments. After finding fault with its disclosures of the earlier payments, which it made from 2020 to 2022, CSL Seqirus voluntarily told the PMCPA that it had breached the U.K. marketing code.
Investigating the case, the PMCPA found that CSL Seqirus failed to identify the absence of valid written agreements with the healthcare organization for three years. The PMCPA voiced concerns about “the number of governance and oversight processes that had failed, including the company's arrangements for approving grants, maintaining accurate records and ensuring the disclosure of transfers of value.”
The cumulative nature of the failings led the PMCPA to conclude CSL Seqirus had suffered wider systemic issues, not an isolated occurrence. CSL Seqirus admitted to a lack of oversight and governance from 2020 to 2022 but expressed confidence in the practices it established in 2024, noting that they led it to reject the 2025 grant application. Efforts to further improve oversight are underway.
“We are undertaking a review of our current processes to assess whether further enhancements are needed to prevent any future deviations and ensure continued compliance with both internal standards and external regulatory requirements,” the company told the PMCPA.
CSL Seqirus’ admission failed to spare the company from the PMCPA’s harshest censure. The watchdog ruled that the company brought discredit upon, or reduced confidence in, the pharmaceutical industry by failing to properly disclose the grants.