The PMCPA has ruled that Otsuka Europe’s involvement with a sponsored symposium webpage breached 11 clauses of the U.K. marketing code. While the PMCPA found fault with many aspects of the webpage, the watchdog opted against hitting Otsuka with its toughest punishment.
A complainant calling themselves an ex-employee triggered the case after becoming concerned about online content for an Otsuka-sponsored symposium at a 2025 healthcare congress. The complainant alleged that the webpage included a misleading sponsorship statement and promoted Otsuka’s Lupkynis (voclosporin), a lupus nephritis drug, off-label. The PMCPA broadly agreed with the complainant.
“The webpage, which was accessible to the public, promoted voclosporin outside the terms of its marketing authorization and omitted important obligatory information such as the prescribing information and adverse event reporting statement,” the PMCPA said.
That finding led the watchdog to conclude that Otsuka had failed to maintain high standards and breached Clause 5.1. Otsuka accepted that its actions amounted to a breach of the clause. However, the PMCPA ruled no breach of Clause 2, which it reserves for failings that bring discredit upon, or reduce confidence in, the pharmaceutical industry.
The PMCPA spared Otsuka from that punishment after concluding that the company “appeared to have been let down” by event organizers. Otsuka was ultimately responsible for the content, but its culpability was limited by the omission of the contentious text from the drafts that it checked before publication.
Clause 5.1 was one of multiple parts of the code that Otsuka accepted it had breached in its response to the complaint. The PMCPA ruled Otsuka had breached clauses related to advertising a prescription-only medicine to the public, making a misleading claim and failing to certify promotional materials, among other failings.
The U.K. watchdog published its findings two years after sharing details of another complaint filed by a former Otsuka employee. In that case, the PMCPA found the company’s Jinarc training website breached Clause 2.