Public reprimand for Novo Nordisk - AUTH/3525/6/21

Novo Nordisk has been publicly reprimanded by the Code of Practice Appeal Board for its arrangements leading to breaches of the Code and a wide-ranging lack of understanding of the requirements of the Code and an obfuscation of responsibilities and the potential impact on patient safety outlined below.

In Case AUTH/3525/6/21 the Code of Practice Panel ruled breaches of the Code including a breach of Clause 2 in relation to a free weight management course which featured Saxenda (liraglutide) that had been sponsored by Novo Nordisk and the provision of an associated Patient Group Direction. Novo Nordisk accepted two breaches of the Code and appealed the remaining rulings of breaches of the Code which were unsuccessful on appeal.

The Appeal Board was very concerned that Novo Nordisk did not recognise that this was a large-scale Saxenda promotional campaign which Novo Nordisk knowingly paid for and which was disguised. In the Appeal Board’s view, the gravity of the breaches were compounded by Novo Nordisk’s failures to recognise that its own behaviour was not compliant with the Code. Novo Nordisk had apparently failed to recognise that the content of the training it sponsored, which focused on its medicine Saxenda, was clearly promotional; failed to recognise that the arrangements, including attendance of Novo
Nordisk representatives at the webinars and their subsequent follow-up with delegates, meant that it could not be considered an arm’s length sponsorship; and failed to recognise that covering the cost of a Patient Group Direction (PGD) was a benefit being offered to individual health professionals and amounted to an inducement. The Appeal Board was concerned about the potential impact on patient safety of providing unbalanced information
to a wide audience, particularly given that the arena of weight loss was a highly emotional arena, and particularly given the lack of balance of Saxenda’s safety profile and side effects when comparing it with its competitors.

In addition to the public reprimand, the Appeal Board also decided to report Novo Nordisk to the ABPI Board under Paragraph 12.1 of the PMCPA Constitution and Procedure.

The ABPI Board decided that Novo Nordisk should undergo an audit. On consideration of the report of the audit and Novo Nordisk’s comments upon it, the ABPI Board would then decide whether any further action was required.