PMCPA raps Gedeon Richter (UK) over ABPI code of practice breaches

Published: 9-Sep-2013

Including promoting an unlicensed medicine


Gedeon Richter (UK), the UK business of the Hungarian pharmaceutical firm, has breached the ABPI Code of Practice for the Pharmaceutical Industry on two occasions and has brought discredit upon and reduced confidence in the pharmaceutical industry, according to the UK's Prescription Medicines Code of Practice Authority (PMCPA).

On the first occasion, an ex-employee of Preglem, a wholly owned subsidiary of Gedeon Richter, complained about the promotion of an unlicensed medicine, Esmya (ullpristal acetate) at a Gedeon Richter meeting to be held in Barcelona, Spain.

The complainant also referred to an invitation to health professionals, which was available on a publicly accessible website.

Gedeon Richter was ruled in breach of the code's Clause 2: bringing discredit upon, and reducing confidence in, the pharmaceutical industry; Clause 3.1: promoting a medicine prior to the granting of a marketing authorisation; Clause 9.1: failing to maintain high standards; Clause 14.2: failing to certify promotional material before issue; and Clause 19.1: providing excessive hospitality.

In the second case, the PMCPA said Gedeon Richter failed to comply with an undertaking by continuing to use promotional meeting invitations that did not include relevant prescribing information, which was in breach of Clause 2, Clause 9.1 and Clause 25: Failing to comply with an undertaking.

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