Gedeon Richter (UK) has breached the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, and has brought discredit upon, and reduced confidence in, the industry, the Code panel has ruled.
The ruling relates to a complaint received concerning the promotion of Esmya (ulipristal acetate) at a meeting to be held in Barcelona in April 2013.
An invitation to health professionals, available on a publicly-accessible website, referred to Esmya, its generic name, its indication and to Barcelona but not the meeting venue, thus appearing to “promote Barcelona rather than the meeting itself,” said the complainant.
The invitation referred to “new Phase III data” evaluating Esmya’s safety and efficacy in treating uterine fibroids. But, said the complainant, if this was Phase III data, it would amount to promoting off-label use as the licence would not be obtained before the meeting. Also, while the material was approved in January 2013, there was no medical signatory available then to certify this foreign travel.
Invitations from Gedeon Richter appeared in the “past events” section of the website of the events company organising the Barcelona meeting, several of which included the product’s name and indication. This “seemed like a concerted effort to promote a prescription-only medicine to the public,” the complainant concluded.
In its ruling, the Prescription Medicines Code of Practice Authority (PMCPA) found that, by sending an uncertified meeting invitation, providing excessive hospitality at that meeting and issuing another meeting invitation which promoted an unlicensed medicine, Gedeon Richter had breached the following Code clauses: - Clause 2: bringing discredit upon, and reducing confidence in, the pharmaceutical industry; - Clause 3.1: promoting a medicine prior to the grant of a marketing authorisation; - Clause 9.1: failing to maintain high standards; - Clause 14.2: failing to certify promotional material before use; and - Clause 19.1: providing excessive hospitality.
The complainant then reported that while Gedeon Richter had undertaken to discontinue forthwith the use of materials found in breach, the invitation relating to Esmya was still on the events company’s website on May 22.
The Code panel ruled that the firm had failed to comply with its undertaking, thus committing further breaches of Clauses 2, 9.1 and 25.
Advertisements giving brief details of the cases appeared in the British Medical Journal and The Pharmaceutical Journal on September 7, and will appear in The Nursing Standard on September 11