Novo Nordisk: multiple failures in transfers of value disclosure (2015–2022) led to Clause 2 breach

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3876/2/24
PartiesComplainants v Novo Nordisk
IssueAllegations about disclosure of transfers of value
Complaint received2 February 2024
Case completed25 October 2024
AppealNo appeal
Period covered2015–2022
Core findings (2021 Code)Breach of Clause 2; Breach of Clause 5.1; plus disclosure breaches (Clauses 28.1, 29.1, 29.2, 31.1)
SanctionsUndertaking received; Additional sanctions: Advertisement

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

  • Three university-based complainants alleged Novo Nordisk failed to properly disclose transfers of value (ToVs) to healthcare organisations (HCOs) and patient organisations (POs) between 2015 and 2022.
  • Allegations covered: unreported ToVs, late reporting, inaccurate descriptions/values, and misreporting on the wrong disclosure platform (Disclosure UK vs company PO disclosures).
  • Novo Nordisk stated there was overlap with its voluntary admission case AUTH/3847/11/23 and said a December 2022 PMCPA audit had identified it lacked a formal ToV collation/disclosure process (and that this had resulted in suspension).
  • Novo Nordisk said it did not have data beyond the five-year retention requirement and therefore did not respond substantively to some 2015–2018 matters.
  • The Panel assessed evidence including Disclosure UK extracts, Novo Nordisk’s PO disclosure webpages (2015–2022), and recipient materials (annual accounts, event materials, acknowledgements of sponsorship).
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Outcome

  • Multiple breaches were ruled across the 2015, 2016, 2019 and 2021 Codes relating to failures to disclose ToVs, late disclosure, and failures to publish required PO support information.
  • Under the 2021 Code, the Panel ruled Clause 5.1 (high standards) and Clause 2 (discredit/reduced confidence) due to the extended period and volume of disclosure failures and governance concerns.
  • Some allegations were found not in breach where the complainants did not meet the burden of proof (eg, insufficient evidence of non-disclosure on Disclosure UK, unclear timing of ToV, or classification uncertainty).
  • The Panel decided not to refer Novo Nordisk to the Appeal Board for further sanctions, noting Novo Nordisk was already subject to audit processes and related sanctions in other ToV cases; however, it noted the Appeal Board would be aware of the case via routine reporting.
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