The Association of the British Pharmaceutical Industry (ABPI) has suspended the membership of Novo Nordisk for two years due to serious breaches of its Code of Practice.
The action was taken by the ABPI Board following an investigation and appeals process conducted by the Prescription Medicines Code of Practice Authority (PMCPA) which found Novo Nordisk to be in breach of the ABPI Code of Practice, including Clause 2 which deals with actions “likely to bring discredit on, or reduce confidence in, the pharmaceutical industry”.
Having considered the case and requesting a further detailed audit of Novo Nordisk’s compliance processes, the ABPI Board decided to suspend Novo Nordisk from ABPI membership.
Susan Rienow, President-Elect, ABPI, said: “The ABPI Board has carefully considered the PMCPA’s case report into Novo Nordisk and the subsequent audit of their compliance procedures.
“The Board expressed significant concern about Novo Nordisk’s compliance activities and the very serious issues identified. As a result, the ABPI Board have taken the decision to suspend Novo Nordisk from ABPI membership.
“Such measures are never taken lightly, but will ensure a rapid return to industry compliance standards as set out in the ABPI Code of Practice”.
This is the eighth occasion in the past 40 years the ABPI board has issued such a significant sanction. As a result, while the company continues to be subject to the ABPI Code and the jurisdiction of the PMCPA, it will not be able to access the wider benefits of ABPI membership. This includes the removal of Novo Nordisk from all ABPI groups, including the ABPI Board, and access to any ABPI information and briefing.
In addition, the Board has stipulated a number of additional actions to demonstrate a rapid return to industry compliance standards. These include requiring the PMCPA to undertake further audits of Novo Nordisk’s compliance in late 2023 and 2024.
These audit reports will need to show clear, significant, and then sustained improvement to industry standards in order for the ABPI Board to consider allowing Novo Nordisk to resume full engagement with the ABPI at the end of the two-year suspension. The ABPI Board has reserved the right to take further decisions following the review of either of the re-audit reports.
The ABPI Board has also insisted that Novo Nordisk must submit a quarterly update to the ABPI Board giving the company’s views on the progress being made against its improvement plan.