Novo Nordisk voluntary admission: ~£7.8m undisclosed transfers of value (2020–2022) and public reprimand (AUTH/3847/11/23)

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Key facts

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Case	AUTH/3847/11/23
Company	Novo Nordisk Limited
Case type	Voluntary admission
Issue	Undisclosed transfers of value
Complaint received / admission date	03 November 2023 (Voluntary admission 3 November 2023)
Case completed	24 April 2024
Period reviewed	2020–2022 (three-year period selected by Novo Nordisk)
Estimated undisclosed value	Approximately £7.8 million
Scale	~500 ToVs; 150+ vendors/bodies; ~10–14% of each year’s total ToVs
Primary root cause described	Inconsistent SAP vendor tagging/classification and related process/oversight weaknesses
Applicable Code years	2019 Code (for 2020 disclosures) and 2021 Code (for 2021–2022 disclosures)
Appeal hearing	No appeal (Panel reported to Appeal Board for sanction consideration)
Sanctions	Undertaking received; Public reprimand

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

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What happened

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Novo Nordisk made a voluntary admission about undisclosed transfers of value (ToVs) of approximately £7.8 million over a three-year period (2020–2022) selected as part of an internal investigation.
The failures related to approximately 500 ToVs to over 150 different vendors and represented about 10–14% of each year’s total ToVs.
Root cause: inconsistent “tagging” of UK vendors in SAP as HCPs, HCOs, POs, ORDMs and members of the public (including patients and journalists), leading to omissions from disclosure reporting.
Contributing process weaknesses included reliance on individuals setting up suppliers to select the correct vendor tag; lack of routine re-checking of vendor status for subsequent engagements; and multiple records for the same vendor with inconsistent tagging.
The issue came to light during work on another matter (Case AUTH/3752/3/23), when discrepancies were noted between amounts paid and amounts specified on agreements, prompting a manual review of payments for 2020–2022.
The Panel noted inconsistencies between figures in the admission and figures in the company’s spreadsheet; the reason for differences was unclear.
CAPA actions described included correcting/resubmitting disclosures, implementing a ToV SOP (effective 24 October 2023) with training, adding compliance approval for vendor set-up/changes, engaging external consultancy support, and adding dedicated resourcing for UK ToV.

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Outcome

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Multiple breaches were ruled under both the 2019 and 2021 ABPI Codes (see Clauses below).
The Panel reported the company to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure to consider further sanctions.
The Code of Practice Appeal Board required Novo Nordisk to be publicly reprimanded.
No additional audit sanction was applied by the Appeal Board because the company was already under an audit cycle following ABPI Board suspension in a separate matter (Case AUTH/3525/6/21, as referenced in the report).

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Clauses

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2019 Code – Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
2019 Code – Breach of Clause 9.1 Failing to maintain high standards
2019 Code – Breach of Clause 23.2 Failing to publicly disclose details of the fees paid to consultants in the UK for certain services rendered by them
2019 Code – Breach of Clause 24.1 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
2019 Code – Breach of Clause 24.4 Failing to make disclosures annually in respect of each calendar year in the first six months after the end of the calendar year in which the transfers of value were made
2019 Code – Breach of Clause 27.7 Failing to make publicly available a list of patient organisations which it supports
2019 Code – Breach of Clause 27.8 Failing to meet the disclosure requirements when engaging patient organisations
2019 Code – No Breach of Clause 23.4 Requirement that fees, expenses and the like due to consultants must be disclosed.
2021 Code – Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
2021 Code – Breach of Clause 5.1 Failing to maintain high standards
2021 Code – Breach of Clause 24.4 (x2) Failing to disclose annually details of the fees and expenses paid to UK individuals, organisations etc for contracted services
2021 Code – Breach of Clause 24.6 (x2) Failing to meet the disclosure requirements for fees and expenses for contracted services
2021 Code – Breach of Clause 28.1 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
2021 Code – Breach of Clause 29.1 Failing to make publicly available annually, a list of patient organisations to which it provides donations, grants or sponsorship or with whom it has engaged to provide contracted services over the reporting period
2021 Code – Breach of Clause 29.2 Failing to meet the disclosure requirements for the provision of donations, grants or sponsorship to a patient organisation
2021 Code – Breach of Clause 30.1 Failing to make publicly available annually details of the fees for certain contracted services paid to members of the UK public, including patients and journalists
2021 Code – Breach of Clause 31.1 Failing to make disclosures annually in respect of each calendar year in the first six months after the end of the calendar year in which the transfers of value were made
2021 Code (2022 associated expenses for contracted services) – No Breach of Clause 24.4 Requirement to disclose annually details of the fees and expenses paid to UK individuals, organisations etc for contracted services
2021 Code (2022 associated expenses for contracted services) – No Breach of Clause 24.6 Requirement to meet the disclosure requirements for fees and expenses for contracted services

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Key facts

What happened

Outcome

Clauses

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