Roche workshop at rheumatology conference ruled promotional and implied off-label use for Mabthera in AAV (AUTH/2598/4/13)

📊

Key facts

⌄

Case number	AUTH/2598/4/13
Parties	Consultant Rheumatologist v Roche Products Limited
Product	Mabthera (rituximab)
Issue	Conference workshop content deemed promotional and implying use in all AAV forms (including CSS) despite licence only for GPA and MPA
Event setting	30-minute workshop within exhibition hall at a national rheumatology conference
Licence timing	Licence for GPA and MPA granted 22 April 2013 (day before presentation); not licensed for CSS
Complaint received	29 April 2013
Case completed	21 June 2013
Applicable Code year	2012
Breach clauses	Clause 3.2; Clause 9.1
No breach clauses	Clause 12.1
Sanction	Undertaking received
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A consultant rheumatologist complained about a Roche-sponsored talk at a national rheumatology conference titled “ANCA-associated vasculitis (AAV) for rheumatologists”.
The complainant alleged the speaker repeatedly said he could not mention rituximab (“the R word”) due to the Code, and urged delegates to attend a subsequent session that would tell them what they needed to know about rituximab in vasculitis.
Roche had booked a 30-minute workshop located within the exhibition hall; organiser guidelines said sessions should be “educational rather than promotional” (terms not defined).
When Roche engaged the speaker, Roche had no licensed medicine in AAV; Mabthera (rituximab) received a licence for GPA and MPA the day before the presentation, but not for CSS.
The speaker agreement (certified January 2013) required a non-promotional presentation with no proactive mention of Mabthera/rituximab.
Despite this, two slides referred to Mabthera/rituximab, including a final slide headed “Biologics in ANCA associated vasculitis” summarising rituximab trial evidence, and the speaker also referred delegates to a later conference session where rituximab in AAV would be discussed.
Roche certified the slides on 11 and 12 April 2013 while the AAV licence was still pending.

⚖️

⌄

The Panel ruled the session was promotional under the Code (despite being highly educational) because of the slides and the speaker’s comments/signposting.
The Panel ruled the presentation implied rituximab could be used in all forms of AAV (including CSS), which was not in accordance with the marketing authorisation.
The Panel ruled Roche failed to maintain high standards because it certified slides while the licence was pending and should have ensured compliance regardless of the speaker’s wishes.
The Panel ruled the promotional nature of the session was not disguised because the programme clearly associated the session with Roche and it was not portrayed as non-promotional.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access