AUTH/3809/8/23: Complainant v Bayer — Advisory board alleged to be pre-licence promotion (No breach on appeal)

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Key facts

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Case	AUTH/3809/8/23
Company	Bayer
Complainant	Anonymous, contactable complainant
Activity	Advisory board held alongside ASRS congress
Date of meeting	31 July 2023
Location	Seattle, USA
Medicine	Eylea (aflibercept); discussion included Eylea 8mg (pre-authorisation at the time)
Marketing authorisation noted	Eylea 8mg granted UK marketing authorisation on 19 January 2024 (after the meeting)
Applicable Code	2021
Clauses considered	2, 3.1, 3.6, 5.1, 10.1, 19.1, 24.2
Final outcome	No breach of Clauses 2, 3.1, 3.6, 5.1, 10.1, 19.1, 24.2
Appeal	Yes — appeal by the respondent; Panel breach rulings overturned
Complaint received	2 November 2023
Case completed	13 March 2025
Sanctions	None stated

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

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An anonymous, contactable complainant challenged a Bayer advisory board held on 31 July 2023 in Seattle, USA, alongside the ASRS congress.
The complainant alleged the meeting was not a genuine advisory board and amounted to pre-licence promotion (“warming the market”) for a new indication/dose (Eylea 8mg).
Concerns raised included: alleged lack/optionality of pre-work; insufficient discussion time; unclear invitation purpose/role/workload; repeat advisory board within ~3 months; commercial presence; too many attendees; extensive slides; payments allegedly above FMV; and that attendees were also Bayer-sponsored congress delegates.
Bayer stated the advisory board had certified objectives and was designed to obtain advice in a rapidly changing anti-VEGF landscape, including discussion of new data presented at the congress; 8 UK ophthalmology advisors attended; contracts were signed in advance; and honoraria were based on a third-party FMV tool.
The Panel initially ruled breaches (including that it was not a genuine advisory board), but Bayer appealed.
The Appeal Board concluded the meeting was a legitimate advisory board with clear concept, detailed minutes, and acceptable arrangements, and overturned the Panel’s breach findings.

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No breach of the Code (final outcome under the 2021 Code).
Appeal Board ruled no breach of Clauses 2, 3.1, 3.6, 5.1, 10.1, 19.1, 24.2 (with the Panel’s breach rulings for Clauses 2, 3.1, 3.6, 5.1, 19.1 and 24.2 overturned on appeal).

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Clause 2 — Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry.
Clause 3.1 — Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation.
Clause 3.6 — Requirement that materials and activities must not be disguised promotion.
Clause 5.1 — Requirement to maintain high standards at all times.
Clause 10.1 — Requirement that companies must not provide inappropriate hospitality.
Clause 19.1 — Requirement that no gift, pecuniary advantage or benefit may be supplied, offered or promised to health professionals or other relevant decision makers in connection with the promotion of medicines, or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.
Clause 24.2 (×2) — Requirement that arrangements for contracted services fulfil specific criteria, including agreeing a written contract or agreement in advance of the commencement of services, and clearly identifying and documenting a legitimate need for the services in advance of requesting the services and entering into arrangements.

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