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Boehringer and Sanofi admit to code breaches

pharmafile | February 13, 2015 | News story | Medical Communications, Sales and Marketing ABPI, Boehringer, PMCPA, Sanofi, afatinib, giotrif 

Sanofi and Boehringer Ingelheim have both admitted to breaching the ABPI Code of Practice, with Sanofi set to be publicly reprimanded for its offense.

Sanofi’s admission came after the company discovered it had not disclosed support it gave to patient organisations in 2013 and 2014. This included the amount paid and the significance of the support, as well as not publicly declaring sponsorship of health professionals’ meetings set up by patient organisations. There were also no written agreements in place for the support provided.

“The systemic failure with respect to the whole process of working with patient organisations was of grave concern,” the PMCPA panel says that is the ruling body of the ABPI, adding that while it appreciates Sanofi’s voluntary admission, the fact that the discovery was only prompted by media criticism into the relationship between pharma and patient organisations in 2014 and had not been noticed earlier was concerning.

“Whilst interactions with patient organisations are a legitimate activity, the arrangements in place at Sanofi at the relevant time were shambolic and shocking. The Appeal Board was extremely concerned that such a long term systemic failure across the entire Sanofi business regarding multiple payments to multiple patient organisations had occurred.”

The panel ruled that Sanofi was in breach of Clause 2 of the code – bringing discredit upon and reducing confidence in the industry. This is the most serious breach possible for a pharma company, and Sanofi will be public reprimanded as a result.

Boehringer breach

Meanwhile, Boehringer admitted that an email it sent detailing results from a trial for lung cancer medicine Giotrif (afatinib) was in breach of the Code.

The email was sent from the company’s German headquarters and reached UK non-health professionals. As it was not certified for UK use and went to people who did not need or had no reasonable interest in the drug, it was ruled as going against the APBI’s rules.

Boehringer says the email was intended for lung cancer health professionals only, but the filters applied when sending it were not restrictive enough.

Breaches were also ruled because the email constituted public promotion of Giotrif and the data was not presented in a balanced or fair way. The absence of prescribing information and prominent instructions for reporting adverse events, as well as ‘misleading’ artwork and not encouraging the ‘rational use’ of Giotrif, were also seen as offenses.

George Underwood

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