AUTH/2174/10/08: Anonymous v Merck Serono — fertility nurse meeting hospitality and alleged off-label selling (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2174/10/08
Parties	Anonymous v Merck Serono
Allegation theme	Alleged inappropriate hospitality; alleged biased sponsorship; suspected off-label selling
Meeting	INSIGHTS annual conference for fertility nurses (1–3 October 2008, Brighton)
Attendees (reported)	124 delegates; 10 steering committee members; 12 Merck Serono staff; 3 event management staff
Speaker issue	After-dinner talk on NHS/changing role of nurse; intended light-hearted but educational; Q&A
Sponsorship (reported)	79 delegates (64%) fully sponsored; 45 (36%) subsidised package (£390); subsidised day rate £60/day
Medicine mentioned	Pergoveris
Authority-requested clauses	Clauses 2, 3.1, 15.9 and 19.1
Applicable Code	2006 Code using the 2008 Constitution and Procedure
Complaint received	13 October 2008
Case completed	10 November 2008
Outcome	No breach (all alleged clauses)
Appeal	No appeal

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

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An anonymous, uncontactable complainant raised concerns about Merck Serono’s sponsorship of an “INSIGHTS” fertility nurse meeting (1–3 October 2008, Brighton).
Allegations included: an after-dinner speaker at the gala dinner was entertainment rather than education; most fully sponsored delegates were from centres allegedly using Merck Serono’s fertility portfolio; and suspicion that the sales team was being asked to sell Pergoveris outside its licensed indication.
The Authority asked Merck Serono to respond under Clauses 2, 3.1, 15.9 and 19.1 (2006 Code, using the 2008 Constitution and Procedure).
Merck Serono stated the meeting was an established educational conference (24th year), with over 13 hours of education delivered by 24 expert speakers, and provided agenda/invitation and supporting materials.
Merck Serono said the after-dinner talk (30–40 minutes) was on NHS issues and the changing role of nurses, delivered by a practising GP; it was intended to be “light-hearted” but educational and relevant, with Q&A.
Merck Serono described delegate sponsorship: 79 delegates (64%) fully sponsored; 45 (36%) offered a subsidised package (£390) and a subsidised day rate (£60/day). It said allocation of fully sponsored places aimed to be equitable and not based on product usage.
On Pergoveris, Merck Serono provided sales training slides and promotional literature and said both reflected the licensed indication as per the SPC.

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No breach of Clause 19.1 (after-dinner speaker and sponsorship allegations).
No breach of Clauses 3.1 and 15.9 (no evidence of being asked to sell Pergoveris outside its licensed indication; materials consistent with SPC).
No breach of Clause 2 (given the above rulings).
No appeal.

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