Boehringer Ingelheim v Bayer Schering Pharma: pre-licence promotion of Xarelto via congress stand and JBJS insert

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Key facts

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Case number	AUTH/2172/10/08
Complainant	Boehringer Ingelheim Limited
Respondent	Bayer Schering Pharma
Product	Xarelto (rivaroxaban)
Comparator mentioned	Pradaxa (dabigatran)
Key activities	UK meeting exhibition stand (Belfast, June 2008); JBJS British Volume insert/supplement (available 4 Sept 2008)
Marketing authorisation date (UK)	1 October 2008
Applicable Code	2006 Code (using 2008 Constitution and Procedure)
Complaint received	09 October 2008
Case completed	23 December 2008
Appeal	No appeal
Breach clauses	2, 3.1 (x2), 7.2 (x2), 7.3, 8.1, 9.10, 18.2
Sanctions	Undertaking received; Advertisement

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

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What happened

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Boehringer Ingelheim complained that Bayer Schering Pharma promoted Xarelto (rivaroxaban) before it received a UK marketing authorisation (granted 1 October 2008).
At the Irish Orthopaedic Association meeting in Belfast (19–20 June 2008), Bayer Schering ran an exhibition stand on VTE with a panel headed “Great Clinical Need for New Anticoagulants Providing:” followed by a list of desirable attributes.
The stand was in a promotional exhibition space and was manned by sales representatives and marketing team members from Bayer Schering’s Republic of Ireland affiliate.
The panel did not make clear that an anticoagulant with that profile (Pradaxa/dabigatran) was already available, which the complainant said was misleading and disparaging.
A leaflet/quiz card invited delegates to “Test your knowledge on VTE and enter a draw to win a book voucher”, which the complainant said was an unacceptable promotional method.
A rivaroxaban supplement distributed with the British Volume of the Journal of Bone and Joint Surgery (available 4 September 2008) was funded by Bayer Schering, circulated in the UK, and contained rivaroxaban content before authorisation.
The supplement’s front cover did not clearly acknowledge Bayer Schering’s sponsorship at the outset; disclosures appeared only within/at the end of articles.
A graph titled “Efficacy of currently available options for venous thromboembolism prophylaxis” used older data (Geerts et al 2001) and did not include dabigatran, making it not up-to-date.
The Panel considered Bayer Schering “inextricably linked” to the supplement’s production (initiated by the company/agency; authors linked to a company symposium; writing support funded by Bayer), and noted it was not formally peer reviewed by JBJS and was effectively a paid-for insert.

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Outcome

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Breach found: the Belfast exhibition panel effectively promoted Xarelto prior to marketing authorisation (pre-licence promotion).
Breach found: the “Great Clinical Need…” heading was misleading and disparaging because it implied no anticoagulant was available with the listed properties.
Breach found: the prize quiz/draw was an unacceptable promotional method.
Breach found: the JBJS insert/supplement promoted Xarelto to UK health professionals prior to marketing authorisation.
No breach found for certain wording alleged to imply availability or exaggerate efficacy (the Panel did not uphold those specific misleading/exaggeration allegations), but noted that where such statements promoted Xarelto, this was covered by the pre-licence promotion breach.
Breach found: the “currently available options” graph was misleading/not up-to-date.
Breach found: sponsorship was not clearly declared at the outset on the supplement front cover.
Breach found: overall poor control and repeated pre-licence promotion brought the industry into disrepute.

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