AUTH/3759/4/23: Boehringer Ingelheim clinical trial recruitment flyer at BSG Conference 2023 – No breach | PMCPA Case

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Key facts

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Case	AUTH/3759/4/23
Company	Boehringer Ingelheim
Activity	Distribution of a clinical trial recruitment/awareness flyer at the British Sarcoma Group (BSG) Conference 2023
Material	A5 flyer included in delegate bags and inserted into conference programme (print and digital)
Trial	Brightline-1 Phase II/III randomised, open-label, multi-centre study in dedifferentiated liposarcoma (DDLPS) (investigational agent vs doxorubicin)
Key allegations	Pre-licence promotion; inappropriate distribution beyond HCPs; misleading implication of licensed indication; solicitation of enquiries about unlicensed medicine
Applicable Code	2021
Clauses considered	3.1, 5.1, 5.6, 6.1
Panel decision	No breach of Clauses 3.1, 5.1, 5.6, 6.1
Complaint received	4 April 2023
Case completed	28 May 2024
Appeal	No appeal

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

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An anonymous, non-contactable complainant challenged Boehringer Ingelheim’s distribution of an A5 flyer about a Phase 2/3 clinical trial (Brightline-1) at the British Sarcoma Group (BSG) Conference (March 2023).
The flyer was included in delegate conference bags and inserted into the conference programme (print and digital on the BSG website), meaning all delegates received it.
The complainant alleged the flyer implied a future licensed indication (eg “first line MDM2 amplified dedifferentiated liposarcoma”), solicited enquiries about an unlicensed medicine via a company email address/QR code, and could reach non-HCPs (eg medical students, research scientists, patient groups).
The complainant also referenced the investigational compound’s Innovation Passport (ILAP) and argued this could make the activity pre-licence promotion.
Boehringer Ingelheim said the flyer was certified (20/01/2023) as non-promotional, clearly stated “For UK healthcare professionals only”, did not name the molecule or describe its mode of action, and contained only factual trial awareness information (eligibility criteria and endpoints) with an investigational disclaimer.
Boehringer Ingelheim stated the conference organiser confirmed all attendees were HCPs; it also submitted the flyer to the HRA as a non-substantial amendment to ethics approval and included an IRAS reference on the flyer.

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No breach of Clause 3.1 (Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation).
No breach of Clause 5.1 (Requirement to maintain high standards at all times).
No breach of Clause 5.6 (Requirement that material should only be made available to those groups of people whose need for or interest in it can reasonably be assumed).
No breach of Clause 6.1 (Requirement that information must be accurate, up-to-date and not misleading).

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