Lundbeck: Vyepti promoted pre-authorisation at Migraine Trust virtual symposium (AUTH/3550/7/21)

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Key facts

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Case	AUTH/3550/7/21
Parties	Health professional v Lundbeck
Product	Vyepti (eptinezumab)
Setting	Migraine Trust International Symposium (MTIS) virtual symposium (live) and on-demand hosting on MTIS website
Main issue	Promotion of eptinezumab prior to UK marketing authorisation; ambiguous sponsorship declaration; on-demand content not properly restricted
Applicable Code year	2019
Complaint received	29 July 2021
Case completed	26 July 2022
Appeal	No appeal
Breach clauses	2; 3.1; 9.1; 9.10
No breach clauses	12.1 (and no breaches found in relation to the Vimeo video link)
Sanctions	Undertaking received; Additional sanctions: Advertisement
Notes on scope	UK delegates were 18.2% (315) and the largest country group; invitation e-shots were sent to all delegates including UK HCPs

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

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A health professional complained that Lundbeck promoted Vyepti (eptinezumab) before UK marketing authorisation via a session at the Migraine Trust International Symposium (MTIS) virtual event (Oct 2020).
The session included slides referencing eptinezumab’s mode of action, dosing, route of administration, EU approval status and clinical data (Promise-2).
Invitation “e-shots” to the Lundbeck symposium were sent to all registered delegates, including UK health professionals (UK was the largest delegate group at 18.2%).
The same symposium recording was later available as on-demand content on the MTIS website; part of the on-demand page was found not to require a registered user log-in (later updated).
The complainant also provided a Vimeo link; Lundbeck said this was a private technical Vimeo account used for hosting videos prior to embedding.
Sponsorship wording in the symposium included “Educational financial support provided by H. Lundbeck A/S”, which the Panel considered ambiguous about Lundbeck’s involvement and influence.

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Breach found in relation to the live symposium and the on-demand video on the MTIS website.
No breach found in relation to the Vimeo link (complainant did not establish that the private Vimeo video was accessible as alleged).
No breach of Clause 12.1 (disguised promotion) on the narrow ground considered (initial impression at the outset).

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