Gedeon Richter: internal training and cycle-meeting slides used outside approval/certification (AUTH/3324/3/20)

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Key facts

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Case number	AUTH/3324/3/20
Complainant	Employee
Company	Gedeon Richter (UK) Ltd
Complaint received	02 March 2020
Case completed	04 February 2021
Applicable Code year	2019
Appeal	No appeal
Therapies/products referenced	Levosert (levonorgestrel IUD), Terrosa (teriparatide), Lenzetto (oestradiol)
Main upheld issue	Use of training items outside approval dates; internal cycle-meeting presentation not certified
Breach clauses	9.1, 14.1
Sanctions	Undertaking received

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

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An employee complained about multiple alleged compliance issues at Gedeon Richter (UK) Ltd, including an alleged plan to conceal patient safety data for a Levosert (levonorgestrel) inserter study.
The complainant alleged the company failed to learn from prior cases and had not implemented new measures to prevent future breaches.
The complainant raised concerns about training materials, including content copied from the International Osteoporosis Foundation website and allegations that older training materials had not been reviewed/re-approved.
The complainant alleged an internal company cycle-meeting included a global colleague’s Terrosa (teriparatide) slide deck that had not been approved/certified and lacked references.
The complainant questioned whether a “global advisory board” (said to be in Germany) was truly advisory versus promotional.
The complainant challenged use of the word “unique” in a Lenzetto (oestradiol) e-detail aid and alleged signatory concerns were over-ruled.

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Breach found: Clause 14.1 and Clause 9.1 (training items used outside approval dates; and an internal cycle-meeting presentation not certified).
No breach: Clauses 2, 7.2, 7.6, 13.1, 14.5, 23.1 (and no breach of 9.1 where it was only alleged but not established).
The Panel did not consider the circumstances warranted a breach of Clause 2 (a sign of particular censure).

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