AbbVie v Bristol-Myers Squibb: BSR symposium alleged to be disguised off-licence promotion for abatacept (No breach)

Case: AUTH/2781/7/15 (reported as AUTH/2781/3/15 in the PDF)
Parties: AbbVie v Bristol-Myers Squibb (BMS)
Meeting: BMS-sponsored medical symposium at British Society of Rheumatology (BSR) 2015
Medicine: abatacept (Orencia)
Result: No breach of the Code

What happened

• AbbVie complained that a 90-minute symposium at BSR 2015 (17:45–19:15 on 29 April) sponsored by BMS was promotional despite being presented as medically led.
• AbbVie alleged no new scientific data were presented and that abatacept was proactively and prominently discussed with benefits emphasised.
• AbbVie alleged the format (multiple presentations) did not allow significant two-way exchange with an audience of ~100.
• AbbVie alleged the symposium encouraged use inconsistent with the marketing authorisation, including discussion of prevention/early disease settings (eg, undifferentiated inflammatory arthritis) and interactive case studies/polls that measured intention to prescribe with an unlicensed dose.
• BMS responded that the symposium was a standalone, non-promotional scientific exchange, organised by medical with no commercial input; sponsorship was clearly declared; no brand colours/logos were used; and sales were instructed not to discuss or invite delegates.
• The symposium comprised three presentations with ~30 minutes for Q&A and the ability for delegates to submit questions/comments via mobile devices during the talks.
• Content included discussion of investigator-initiated studies (including APIPPRA and AARIA involving abatacept for prevention/at-risk populations) and other therapies/studies; BMS argued the discussion was balanced and contextual.

Outcome

• The Panel accepted that companies may sponsor symposia at third-party meetings and noted the event was clearly labelled as “A Bristol-Myers Squibb Medical Symposium”.
• The Panel noted the symposium advertising materials did not reference Orencia and did not use brand colours/logos.
• The Panel considered the arrangements supported scientific exchange: invitations were in delegate bags; not promoted from a promotional stand; sales were instructed not to promote attendance; BMS appeared to have no control over who attended.
• Although unlicensed uses of abatacept were discussed (eg, APIPPRA/AARIA), the Panel did not consider the tone/content would encourage off-label use for prevention, nor that abatacept was given greater prominence than other medicines.
• AbbVie did not, on the balance of probabilities, prove disguised promotion or promotion inconsistent with the marketing authorisation.
• Because the Panel did not consider the symposium to be promotional, it did not require prescribing information or an adverse event reporting statement for delegates.
• No breach was ruled for all alleged clauses.

Clauses

• Clause 12.1 (alleged disguised promotion) – No breach
• Clause 4.1 (alleged absence of prescribing information) – No breach
• Clause 4.10 (alleged absence of adverse event reporting statement) – No breach
• Clause 3.2 (alleged promotion inconsistent with marketing authorisation) – No breach
• Clause 9.1 (alleged failure to maintain high standards) – No breach
• Clause 2 (alleged discredit to/reduction of confidence in the industry) – No breach

Sanctions

• Not stated (no breach case; no additional sanctions recorded).

Why this matters

• Scientific exchange at congress symposia can legitimately include discussion of unlicensed studies, but the line between exchange and promotion is judged on content and arrangements, not which internal department “owns” the activity.
• Even a single slide heading (eg, “Why should we try abatacept?”) can be interpreted as a call to action; context and framing are critical.
• Interactivity and balance (multiple therapies, clear uncertainty, and robust Q&A) can be decisive in demonstrating non-promotional intent.

Where teams slip up

• Assuming “medical-led” equals “non-promotional” without stress-testing how the audience could interpret wording, emphasis, and calls to action.
• Discussing unlicensed indications without clear signposting that the use is investigational and without balanced statements about limitations/uncertainty.
• Allowing commercial teams to amplify attendance (even informally) or creating the perception that the symposium is a brand event.
• Over-reliance on slide counts (eg, “only X slides mention our product”) rather than assessing tone, prominence, and take-home messages.

Control that would have prevented it

• A documented scientific exchange checklist for sponsored symposia covering: balanced agenda, multi-therapy context, explicit investigational status for off-label data, and avoidance of suggestive headings.
• Clear sales force instructions (and evidence of briefing) not to invite/direct delegates or discuss the symposium content.
• Pre-event compliance review focused on “appearance of promotion” (titles, slide headings, polling questions, and conclusions), not just factual accuracy.