Gedeon Richter has been found to have breached the UK pharma industry’s Code of Practice, according to the the Association of the British Pharmaceutical Industry (ABPI).
The Prescription Medicines Code of Practice Authority (PMCPA), which administers the code, said the Hungary-based company failed to comply with several clauses by “sending an uncertified meeting invitation and providing excessive hospitality at that meeting, and for issuing another meeting invitation which promoted an unlicensed medicine”.
The breaches included 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 issue; and Clause 19.1 – providing excessive hospitality.
The company also breached Clause 2 – “bringing discredit upon, and reducing confidence in, the pharmaceutical industry”.
Under provisions in its constitution and procedure, the PMCPA advertises brief details of all cases where companies are ruled in breach of Clause 2 – the companies in question are required to issue a corrective statement or be the subject of a public reprimand.
The advertisements mentioning Gedeon Richter appeared in the BMJ and The Pharmaceutical Journal on September 7, 2013 and The Nursing Standard on September 11, 2013.
The company decided not to appeal the rulings. Zsuzsa Beke, its head of public relations and public affairs, told PMLiVE that the breach was “the result of unsatisfactory internal controls”.
The breach has prompted an overhaul of compliance and governance procedures at Gedeon Richter, said Beke, including “an extensive review of procedures pertaining to all aspects of promotion of product, including a new electronic compliance and sign off procedure”.
All staff have been trained in the new procedures, which are fully compliant with the ABPI code of conduct. An external pharmaceutical industry specific consultant has been retained to advise the company on ABPI code developments and their implementation.
Gedeon Richter has also parted ways with an external agency, bringing work back in house in order to maintain standards, and the UK organisation has seen a change of senior personnel.
“We are confident we have the processes and procedures in place to abide by the word and spirit of the ABPI code of conduct and that there will be no repeats of code of conduct failures,” said Beke.