Gedeon Richter: Barcelona Esmya meeting invitations—unacceptable arrangements, lack of certification, and pre-licence promotion (AUTH/2575/2/13)

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Key facts

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Case number	AUTH/2575/2/13
Complainant	Ex-employee
Company	Gedeon Richter (Preglem subsidiary referenced)
Medicine	Esmya (ulipristal acetate)
Therapy area	Uterine fibroids
Meetings at issue	Barcelona April 2013; Barcelona 2–3 March 2012 (invitation sent Dec 2011)
Main issues	Meeting arrangements/hospitality and implied duration; lack of certification; pre-licence promotion (2012 invite); alleged public advertising via event website
Applicable Code year	2012
Complaint received	05 February 2013
Case completed	07 May 2013
Appeal	No appeal
No breach clauses	Clause(s) 2, 3.2 and 22.1
Breach clauses	Clause(s) 2, 3.1, 9.1 (x2), 14.2 and 19.1
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 “save the date” invitations for an Esmya (ulipristal acetate) meeting in Barcelona (April 2013), which were accessible via an events company website.
The invitation referenced Esmya branding, ulipristal acetate, uterine fibroids, and “new phase III clinical data”.
The invitation asked recipients to save 12, 13 and 14 April, but the main meeting content ended midday on 13 April; an additional UK-only session (13 April 14:00–17:00) was not mentioned on the save-the-date card.
Some UK delegates stayed additional nights (including two or three nights’ accommodation paid) and dinner was provided for those staying on the Saturday night.
The company acknowledged it could not demonstrate the April 2013 invitation had been certified by a registered medical practitioner or UK registered pharmacist due to personnel changes.
The complainant also raised similar invitations for a Barcelona meeting in March 2012, where invitations were sent before Esmya’s first authorization (February 2012).

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No breach for the April 2013 invitation promoting Esmya for an unlicensed indication (Clause 3.2).
Breach for unacceptable meeting arrangements for the April 2013 Barcelona meeting (Clause 19.1).
Breach for failure to certify the April 2013 invitation for a meeting outside the UK (Clause 14.2).
No breach for alleged advertising of a prescription only medicine to the public via the events company website (Clause 22.1).
Breach for failure to maintain high standards (Clause 9.1) in relation to the April 2013 arrangements/certification issues.
Breach of Clause 2 for the April 2013 arrangements bringing discredit upon and reducing confidence in the industry.
Breach for the December 2011 invitation/preliminary programme for the March 2012 Barcelona meeting promoting an unlicensed medicine (Clause 3.1).
Breach of Clause 9.1 in relation to the 2012 invitation/promotional material.
The Panel did not rule a Clause 2 breach for the 2012 invitation circumstances (Clause 2 reserved for particular censure).

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