Anonymous v Bayer (AUTH/3188/4/19): Third-party email linked Xarelto to sponsored anticoagulation therapy review service

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Key facts

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Case	AUTH/3188/4/19
Parties	Anonymous v Bayer
Topic	Sponsored therapy review services (third-party provider)
Medicine mentioned	Xarelto (rivaroxaban)
Trigger for complaint	Internal third-party email dated 14 August 2018 linking “Xarelto (rivaroxaban) AF review” to Bayer-funded service
Services referenced	ASC2 (Anticoagulation Support Clinic) (active); SPAF1 (Stroke Prevention in Atrial Fibrillation) (withdrawal decision May 2018; terminated 27 September 2018); proposed CAD/PAD review (not commissioned)
Complaint received	30 April 2019
Case completed	14 October 2020
Applicable Code	2016
Breach clauses	9.1
No breach clauses	2, 12.1, 19.2
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	Appeal by complainants (Clause 2); unsuccessful

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

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What happened

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An anonymous, contactable group (described as GPs, NHS leaders, pharmacists, NHS patients and staff of a named third-party service provider) complained about sponsored therapy review services delivered by that third party for multiple pharma companies, including Bayer.
The complaint focused on an internal email (14 August 2018) from a very senior employee at the third party to its clinical team (pharmacists) which, for Bayer, stated: “Bayer are committed to the Xarelto (rivaroxaban) AF review for 2018 with a focus on [ASC]2 clinics…”.
The email also referenced Bayer’s “strategic focus” to seek a licence extension for rivaroxaban into coronary artery disease/peripheral artery disease (CAD/PAD) and said a proposal for a new review had been submitted.
Complainants alleged the email demonstrated commercial bias—linking therapy reviews to sponsor products—and argued this was misleading and reduced confidence in the industry (Clause 2).
Bayer explained it funded two AF-related services historically with the third party: SPAF1 (launched 2012; withdrawal decision May 2018; terminated 27 September 2018) and ASC2 (launched 2015; active service). The email referred to ASC2 clinics.
Bayer said the reference to Xarelto in the email was an error by the third party and inconsistent with the service’s legitimate objectives and approved name; Bayer’s written documentation did not link the service to a Bayer product and the authorising clinician/HCO retained control of prescribing decisions.
For CAD/PAD, Bayer said it had only received a proposal; there was no contract, no approved documentation, and no commissioned service.

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Outcome

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Breach found: Clause 9.1 (2016 Code).
No breach: Clauses 2, 12.1, 19.2 (2016 Code).
The Panel considered Bayer responsible for the third party’s email as it related to a Bayer-funded service, and found high standards had not been maintained because the email linked the therapy review service to Xarelto.
However, the Panel did not find sufficient evidence (on the balance of probabilities) that the service arrangements failed to meet Clause 19.2 requirements or that the service was disguised promotion (Clause 12.1).
The Appeal Board upheld the Panel: the Clause 9.1 breach stood; no Clause 2 breach was warranted because the email was a single internal communication and there was no evidence it impacted service delivery.
For CAD/PAD, the Panel and Appeal Board found no evidence Bayer commissioned such a service or linked a possible CAD/PAD service to rivaroxaban; no breaches were ruled for that aspect.

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