The U.K. drug marketing watchdog has ruled that a presentation calling the European Medicines Agency (EMA) “stupid” brought discredit on the pharma industry.
A former employee of Angelini Pharma alerted the PMCPA to the presentation, according to a case report from the self-regulatory body. The presentation took place at a promotional meeting in Milan in November 2023 that Angelini had organized and funded for an international audience. Two U.K. speakers were engaged to present at the event, and the U.K. team hosted 13 delegates.
One contracted presenter, reportedly a non-native speaker, made the following comment, per the complaint: “If a substance is successful and better than placebo, like cenobamate was, then we get a labeling, and the European Medicine Agency is stupid enough just to allow the labeling for add-on therapy only—no monotherapy license because they say we get the license only for what the studies showed.”
The complainant accused Angelini, by providing a platform for the comments, of disparaging the EMA and undermining the competence of a licensing authority, thereby bringing discredit on the industry.
For its part, the company’s defense centered on the fact that English isn’t the speaker’s first language.
Focusing on the presenter’s use of the word “stupid,” Angelini said it recognized “that the phraseology used by the speaker was not appropriate” but rejected at length the idea that the choice of a single word by a non-native speaker had brought discredit on the industry.
“Indeed, to make such a ruling might be regarded as elitist; or discriminatory,” Angelini said. “Few native English [healthcare professionals] could even make the same presentation (let alone perfectly) in Dutch, French, German, Spanish, Italian or Greek.”
The PMCPA panel undid Angelini’s defense by looking beyond the use of the word “stupid.” As a whole, the presentation was a “dismissal of the EMA and a criticism of its decisions and methodology,” the PMCPA said in its decision, noting that the speaker at one point said, “There’s certainly one institution I do not like and that is the European Medicine Agency” early in the presentation, which focused overall on criticizing EMA rulings.
Because companies are responsible for the acts of their consultants, agents and third parties, the PMCPA ruled Angelini had breached Clause 2 of the Association of the British Pharmaceutical Industry's (ABPI's) code of practice, indicating that the drugmaker brought discredit on the industry—the watchdog's most serious ruling.
A second Clause 2 breach was triggered by Angelini’s uploading of the presentation to a portal. The company initially said it had edited out the EMA comments but later said that statement was erroneous.
The two Clause 2 breaches were part of a broader set of potential violations. Angelini successfully defended itself against many of the allegations, including other claims that it had brought discredit on the industry, but the PMCPA still ruled a total of 54 breaches spread across seven clauses of the ABPI code, reflecting multiple failures to certify promotional materials and include required information in slides and videos.