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Drug manufacturer Novo Nordisk has been reprimanded by the Prescription Medicines Code Of Practice Authority (PMCPA) for failing to disclose payments of around £7.8m to individuals and organisations in the UK between 2020 and 2022.
The self-regulatory body, established in 1993 by the Association of the British Pharmaceutical Industry to independently administer its codes of practice, said on 5 July 2024 that it had “publicly reprimanded” the company following a voluntary submission from Novo Nordisk in 2023.
The decision to issue the reprimand related to approximately 500 undisclosed payments made to more than 150 healthcare organisations and professionals between 2020 and 2022, and included fees paid to patients and journalists in the UK.
As a result, the PMCPA ruled that the company was in breach of 16 clauses of the ABPI’s Code of Practice, including “bringing discredit upon, and reducing confidence in, the pharmaceutical industry” and “failing to document and publicly disclose annually certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organisations”.
In the reprimand notice, the PMCPA said its Appeal Board described the breach as “extremely serious” and that it was “concerned that there appeared to be fundamental governance failures”.
“The wide ranging systemic failings apparent to the Appeal Board included inadequate training, processes and monitoring,” it added.
In a statement given to The Pharmaceutical Journal on 8 July 2024, Novo Nordisk said: “In 2023, Novo Nordisk made a voluntary admission to the PMCPA after internal investigations — conducted by us as part of a review of our compliance systems — found historical payments that had not been disclosed.
“These payments are for legitimate activities but had been incorrectly categorised in finance systems as a result of human error.
“We accept the PMCPA’s decision to rule the relevant breaches of the two Codes of Practice, which applied during the timeframe for this case and agreed that this was the appropriate ruling as part of our voluntary admission.”
In March 2023, Novo Nordisk was suspended from the ABPI for two years for breaching its Code of Practice, after the company sponsored a weight management course linked to promoting its weight-loss drug Saxenda (liraglutide).
PMCPA’s notice said: “The Appeal Board noted that the company was currently under an audit cycle as a result of its suspension … and therefore considered that an additional audit sanction by the Appeal Board was not necessary.”
It added that the Appeal Board expected Novo Nordisk’s upcoming October 2024 re-audit “would, among other things, evaluate the company’s current processes in relation to disclosure of transfers of value”.
