The U.K.’s drug marketing watchdog has slammed Novo Nordisk for failing to disclose transfers of around 7.8 million British pounds sterling ($10 million) to more than 150 bodies.
Novo has had a series of run-ins with the Prescription Medicines Code of Practice Authority (PMCPA), leading to its suspension from U.K. pharma trade group ABPI. While looking into one complaint pursued by the PMCPA, Novo found discrepancies between the amounts it paid and the amounts specified on its agreements.
The company responded by reviewing the payments it made in 2020, 2021 and 2022, revealing that its inconsistent “tagging” of U.K. vendors such as healthcare professionals and organizations had caused it to under-report its payments.
Novo reported itself to the PMCPA. In the voluntary admission, the Danish drugmaker said it believed the PMCPA should consider breaches of multiple clauses, including the potential that its actions brought discredit on, and reduced confidence in, the pharma industry.
The PMCPA panel ruled Novo breached the discredit clause in the 2019 and 2021 versions of the code. There was worse to come. The panel found a discrepancy between Novo’s spreadsheet and admission. The spreadsheet listed 7.8 million British pounds in undisclosed payments. The admission said 6.4 million British pounds. The panel noted “further concerns about some of the calculations.”
After weighing all the evidence, the panel reported the company to the appeal board. The board said the scale of the undisclosed payments, and length of time they cover, was “extremely serious” and expressed concerns “that there appeared to be fundamental governance failures.” The gravity of the situation led the board to recommend a public reprimand of Novo.
The reprimand noted “wide-ranging systemic failings ... [including] inadequate training, processes and monitoring” but Novo escaped an additional audit sanction because of its suspension from the ABPI. An audit is planned for October as part of the suspension proceedings, providing an existing opportunity to evaluate Novo’s current processes for disclosing transfers of value.
Novo made the case that it has addressed the problems in its interactions with the PMCPA. The company has “considerably increased” its resources and focus in the area, tasking eight staff and four consultants with handling the work. The consultancy has helped many pharma companies, Novo said, and collated the information for the submission the drugmaker made in 2023. Novo has retained the consultancy.