Failures at Novartis have prompted U.K. marketing watchdog the PMCPA to warn that “companies should be on high alert” when working with third parties to promote materials about medical conferences.
The PMCPA issued the warning after reviewing a complaint about an email that a third-party medical publisher sent to doctors. A U.K.-based physician who opened the email said they expected an unbiased report about the European Society for Medical Oncology’s 2023 congress. Instead, the doctor said in the complaint, they found a promotional email for Novartis’ Pluvicto, “disguised very carefully” as a prostate cancer update.
Novartis admitted the email broke several rules set out in the U.K. marketing code. In a long response to the PMCPA, the Swiss drugmaker outlined the processes it has established to prevent global teams from publishing materials that break U.K. rules. Novartis said the processes were bypassed by mistake.
“A Novartis Global associate mistakenly used the term ‘Europe’ when instructing [the third-party medical publisher] on the location of HCPs to target, rather than specifying only those HCPs working within the European Union,” Novartis said. “This error is the root cause of the material being made available to healthcare professionals practising in the U.K.”
Because the material was inadvertently sent to U.K. physicians, the promotion never underwent review for compliance with the marketing code enforced by the PMCPA. Novartis admitted that “high standards were not maintained in this instance.”
However, while accepting it broke some rules, the drugmaker argued the case didn’t warrant the PMCPA’s most serious ruling—that it had discredited the industry—because the wrongdoing stemmed from human error.
“Human error and the isolated actions of one single employee who has failed to follow our policies and provide appropriate targeting instructions does not, and should not, reflect the diligent efforts that Novartis and its associates make to ensure that the conduct of the company accords with the highest standards and therefore complies with the requirements of the Code,” the company said.
The PMCPA panel felt differently, concluding that Novartis “had, on balance, reduced confidence in, and brought discredit upon, the industry.” The conclusion reflected the cumulative impact of the use of the EU product information, the circulation of the email to a broad audience and the failures of the internal governance processes, according to the panel.
“Companies should be on high alert when considering compliance and the integration of their material into third-party material about medical conferences which was likely to discuss and/or promote off-licence indications of their products,” the PMCPA added.