AUTH/2651/11/13: Health professional complaint about alleged promotion of unlicensed pipeline medicines at ESGO stand (No breach) – Merck Sharp & Dohme | PMCPA Case

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Key facts

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Case number	AUTH/2651/11/13
Complainant	Anonymous, non-contactable health professional
Company	Merck Sharp & Dohme
Allegation	Alleged promotion of unlicensed medicines via exhibition stand panels at ESGO 2013
Event	European Society of Gynaecological Oncology (ESGO), Liverpool, 19–22 October 2013
Materials at issue	Six exhibition stand posters/panels including PD-1, CDK, ERK pathway posters; oncology pipeline poster; corporate poster; and PROCEED phase III trial (vintafolide) recruitment poster
Applicable Code year	2012
Clauses considered	2, 3.1, 9.1, 22.1, 22.2
Panel decision	No breach of the Code
Appeal	No appeal
Complaint received	8 November 2013
Case completed	11 December 2013

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

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An anonymous, non-contactable health professional complained that Merck Sharp & Dohme (MSD) promoted unlicensed medicines at the European Society of Gynaecological Oncology (ESGO) meeting in Liverpool (19–22 Oct 2013).
The complaint focused on large exhibition stand panels describing MSD’s oncology pipeline (eg PD-1 inhibitor, CDK inhibitor, ERK inhibitor), mechanisms of action and ongoing trials, which the complainant said looked promotional and could prompt enquiries (ie not “unsolicited”).
The complainant also raised concern that patient groups/carers might be present at conferences and could be misled by such materials.
MSD said the stand was an unbranded medical/scientific affairs stand, with no promotion of licensed products, no handouts, and staffed only by medical affairs (pharmacist medical information specialist and an MSL; no sales/marketing).
MSD said the panels were designed to support legitimate scientific exchange during development: low-key scientific style, investigational statements included, no efficacy/safety claims, no regulatory timeline discussion, and reactive responses only.
The Panel reviewed six posters/panels, including: pathway/target posters (ERK, PD-1, CDK), a pipeline poster, a corporate poster, and a PROCEED trial poster for a phase III trial of vintafolide in platinum-resistant ovarian cancer with “Now enrolling…” and “to learn more” trial participation prompts.

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No breach of the Code was ruled.
No breach of Clause 3.1 (promotion prior to marketing authorisation) in relation to the five posters, including the PD-1 poster (concerns noted about in vivo/in vitro data, but limited).
The Panel expressed concerns about the PROCEED trial recruitment poster and whether, in the context of an exhibition stand, it met the requirements for legitimate scientific exchange; however, on balance and given the narrow grounds of the complaint, it did not amount to promotion of an unlicensed medicine.
The complainant did not discharge the burden of proof regarding alleged promotion to the public/patient groups; no breach of Clauses 22.1 and 22.2.
No breach of Clauses 2 and 9.1.
No appeal.

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