Gedeon Richter breached an undertaking after a meeting invitation stayed live online without prescribing information (AUTH/2601/5/13)

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Key facts

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Case number	AUTH/2601/5/13
Parties	Ex-employee / Director v Gedeon Richter
Issue	Breach of undertaking relating to a meeting invitation hosted on an events company website without prescribing information
Product / imagery referenced	Esmya (ulipristal acetate) brand imagery (prescribing information absent on invitation)
Invitation reference	GRADV 13/0034
Meeting date	14 May 2013
Complaint received	02 May 2013
Case completed	06 June 2013
Applicable Code year	2012
Breach clauses	Clause 2, Clause 9.1, Clause 25
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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An ex-employee alleged that a meeting invitation available on an events company’s website (seen 22 May 2013) breached an undertaking Gedeon Richter had given on 15 April 2013 in an earlier case (AUTH/2580/2/13).
The invitation related to a meeting on 14 May and used brand imagery associated with Esmya (ulipristal acetate), making it likely to be seen as promotional.
The invitation did not include prescribing information.
Gedeon Richter argued it believed the undertaking would not be “in force” until the complainant’s appeal in the earlier case was concluded, and said it was implementing SOPs and an electronic approval tool.
The matter was taken up by the Director because it concerned an alleged breach of an undertaking (the Authority ensures compliance with undertakings).

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Breach of Clause 25 (failure to comply with an undertaking).
Breach of Clause 9.1 (high standards not maintained).
Breach of Clause 2 (bringing discredit upon and reducing confidence in the pharmaceutical industry).
No appeal in this case.

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