AUTH/2814/12/15: Boehringer Ingelheim symposia at ESC Congress (Pradaxa) – no breach, but Panel raised concern about unlicensed reversal agent slide | PMCPA Case

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Key facts

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Case number	AUTH/2814/12/15
Complainant	Anonymous, non-contactable (described as a UK health professional)
Company	Boehringer Ingelheim
Product(s)	Pradaxa (dabigatran)
Setting	ESC Congress, London (29 Aug–2 Sep 2015); sponsored satellite symposium (31 Aug 2015)
Material at issue	Slide stating “Prescribing information is available at this meeting”; symposium content alleged to be off-label; mention of medical research grants
Allegation	Off-label discussions and grant discussions at symposia where prescribing information was available
Applicable Code year	2015
Clauses considered	2, 3.1, 3.2, 9.1, 19.1
Panel decision	No breach of the Code
Notable Panel comment	Concern that a slide in the fourth presentation appeared to promote an unlicensed dabigatran reversal agent prior to marketing authorisation; requested BI be advised
Complaint received	21 December 2015
Case completed	8 February 2016
Appeal	No appeal

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

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An anonymous, non-contactable UK health professional complained about Boehringer Ingelheim medical symposia at the European Society of Cardiology (ESC) Congress in London (29 Aug–2 Sep 2015).
The complainant alleged the symposia included off-label discussions and discussion of medical research grants, while slides stated “Prescribing information is available at this meeting”.
The complainant provided a photo of a Boehringer Ingelheim slide (“Panel discussion and Q&A”) from a sponsored satellite symposium.
Boehringer Ingelheim explained the symposium (“Your patients, your practice, your choice: NOACs in the clinic”) comprised four dabigatran-focused talks and a Q&A; it supplied copies of all presentations and said content was consistent with Pradaxa’s marketing authorisation.
Boehringer Ingelheim also explained it supported an ESC research grant programme (“ESC Grants for Medical Research Innovation”); the agreement was not dabigatran-specific and required NOAC proposals to include more than one NOAC.
During review, the Panel noted the fourth presentation included claims about Boehringer Ingelheim’s specific reversal agent for dabigatran which did not have an EU licence; the Panel expressed concern this could amount to promotion of an unlicensed medicine (though this was not part of the complaint).

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No breach of the Code was ruled.
No breach of Clause 3.2: no evidence Pradaxa was promoted outside its marketing authorisation / SPC.
No breach of Clause 3.1: the complainant did not allege promotion of an unlicensed medicine, so the Panel was obliged to rule no breach on that point.
No breach of Clause 9.1 and consequently no breach of Clause 2: high standards were not found to have been breached.
No breach of Clause 19.1 (and consequently Clauses 9.1 and 2) regarding the research grant information shown at the end of sponsored sessions.
However, the Panel asked that Boehringer Ingelheim be advised of its concerns that a slide in a promotional symposium appeared to promote an unlicensed reversal agent prior to marketing authorisation.

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