Gedeon Richter: Esmya meeting invitation ruled promotional without prescribing information (AUTH/2580/2/13)

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Key facts

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Case number	AUTH/2580/2/13
Parties	Ex-employee v Gedeon Richter
Material	Meeting invitation (Manchester, 6 March 2013) titled “Selective Progesterone Receptor Modulators (SPRMs) and a new treatment for uterine fibroids”
Product	Esmya (ulipristal acetate)
Allegations	Invitation was promotional without prescribing information (Clause 4.1); POM promoted to the public via events website (Clause 22.1); Clause 2
Applicable Code year	2012
Complaint received	20 February 2013
Case completed	30 May 2013
Panel decision	Breach Clause 4.1; No breach Clauses 22.1 and 2
Appeal	By complainant (Clauses 2 and 22.1); unsuccessful
Sanctions	Undertaking received; additional sanctions not stated

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

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An ex-employee complained about an invitation (ref GR-ADV 13/0010) to a Manchester meeting on 6 March 2013 titled “Selective Progesterone Receptor Modulators (SPRMs) and a new treatment for uterine fibroids”.
The invitation said the meeting was “supported by an unrestricted educational grant” from Gedeon Richter (UK) Ltd (Women’s Health Division).
Gedeon Richter marketed Esmya (ulipristal acetate), indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
The invitation featured Esmya-associated brand imagery and referenced a talk including “Patient & surgical experience post treatment of ulipristal acetate”.
The complainant alleged the invitation was promotional and should have included prescribing information (Clause 4.1).
The complainant also alleged the invitation was publicly accessible on an events management company website and therefore promoted a prescription-only medicine to the public (Clause 22.1), and that the conduct warranted Clause 2 censure.
On appeal, the complainant cited tweets by the events management company about other meetings mentioning ulipristal acetate and uterine fibroids, arguing this showed active public promotion.

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Breach of Clause 4.1: The Panel ruled the invitation promoted Esmya and should have included prescribing information; it did not.
No breach of Clause 22.1: The Panel (and Appeal Board) did not consider that the invitation’s availability on the events company website, in the circumstances described, constituted promotion of a POM to the public.
No breach of Clause 2: The Panel (and Appeal Board) did not consider the circumstances warranted Clause 2 censure.
The complainant’s appeal (Clauses 2 and 22.1) was unsuccessful.
The Appeal Board expressed being “extremely concerned” that Gedeon Richter had provided inaccurate information about the events company’s role (it was not “entirely passive” given tweets about other meetings).

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