Novo Nordisk: delayed Disclosure UK reporting and weak governance over sponsored third-party materials (AUTH/3763/4/23)

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Key facts

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Case	AUTH/3763/4/23
Parties	Complainants v Novo Nordisk Ltd
Complaint received	26 April 2023
Case completed	21 June 2024
Subject matter	Transfers of value disclosures (Disclosure UK) and sponsored activities involving a training provider and a pharmacy services provider
Key amounts mentioned	Training provider ToV disclosed late: 2020 (£168,000 sponsorship; £750 fee for service; £11,040 fee for service) and 2021 (£42,900 sponsorship); total referenced £222,690
Why disclosures were late/missing (as submitted)	Training provider and pharmacy services provider not categorised as HCOs in finance system, so payments were not included in ToV reports
Appeal	Appeal by the complainants; one Panel no-breach ruling on Clause 5.1 (2021 Code) overturned (poor governance over post-contract use of sponsored materials)
Sanctions	Undertaking received; additional sanctions not stated

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

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What happened

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Two academic complainants raised concerns about Novo Nordisk’s Disclosure UK reporting and third-party activities linked to a training provider and a pharmacy services provider.
Transfers of value to the training provider (2020 and 2021) were not disclosed within the required timelines because the organisation was not categorised as a healthcare organisation (HCO) in Novo Nordisk’s finance system.
Payments to the training provider were submitted late to Disclosure UK: 2020 payments submitted 17 November 2022; 2021 payment submitted 22 December 2022.
Novo Nordisk contracted (Nov 2021–Oct 2022) with the pharmacy services provider to sponsor multiple activities including a weight management e-tool and an online weight loss service ad campaign; the pharmacy services provider was also not identified as an HCO in Novo Nordisk’s finance system, so transfers of value were not submitted to Disclosure UK.
Material/communications associated with the pharmacy services provider’s weight management service did not clearly disclose Novo Nordisk’s sponsorship on a referenced webpage, despite contractual requirements to do so.
Complainants alleged Novo Nordisk indirectly promoted Wegovy to the public via the pharmacy services provider’s patient-facing website and social media. The Panel (and Appeal Board) did not hold Novo Nordisk responsible for the website’s Wegovy content because it appeared after the sponsorship contract ended.
However, the Appeal Board was concerned that sponsored materials created during the contract could continue to be used after contract end to direct people to the pharmacy services provider’s website, without Novo Nordisk control/oversight.

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Outcome

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Breach of Clause 9.1 (2019 Code) – failing to maintain high standards.
Breach of Clause 24.4 (2019 Code) – failing to make disclosures annually in the first six months after the end of the relevant calendar year.
Breach of Clause 5.1 (x2) (2021 Code) – failing to maintain high standards (including one no-breach ruling overturned on appeal due to poor governance over post-contract use of sponsored materials).
Breach of Clause 5.5 (2021 Code) – failing to be sufficiently clear as to the company’s role (sponsorship not clearly declared on relevant material).
Breach of Clause 28.1 (2021 Code) – failing to document and publicly disclose annually certain transfers of value (pharmacy services provider).
Breach of Clause 31.1 (x2) (2021 Code) – failing to make disclosures annually in the first six months after the end of the relevant calendar year.
No breach findings were made for multiple clauses, including that Novo Nordisk was not found responsible for direct-to-consumer advertising of Wegovy via the pharmacy services provider’s website at the time in question.

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Clauses

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Breach of Clause 9.1 (2019 Code) – Failing to maintain high standards
Breach of Clause 24.4 (2019 Code) – 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
Breach of Clause 5.1 (x2) (2021 Code) – Failing to maintain high standards
Breach of Clause 5.5 (2021 Code) – Failing to be sufficiently clear as to the company’s role
Breach of Clause 28.1 (2021 Code) – 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
Breach of Clause 31.1 (x2) (2021 Code) – 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
No Breach of Clause 19.2 (2019 Code) – Requirements relating to the provision of medical and educational goods and services in the form of donations, grants and benefits in kind
No Breach of Clause 24.1 (2019 Code) – Requirement to document and publicly disclose annually certain transfers of value made directly or indirectly to health professionals, other relevant decision makers and healthcare organisations
No Breach of Clause 24.8 (2019 Code) – Requirement for a transfer of value made to an individual health professional or other relevant decision maker indirectly via a healthcare organisation to be disclosed once only, preferably as a transfer to the individual concerned
No Breach of Clause 24.9 (2019 Code) – Requirement for transfers of value to be disclosed on an aggregate basis where recipients of such transfers cannot be identified for legal reasons
No Breach of Clause 5.1 (x2) (2021 Code) – [1x Panel no breach ruling upheld at appeal] Requirement to maintain high standards
No Breach of Clause 10.9 (2021 Code) – Requirement to disclose when events/meetings are sponsored by pharmaceutical companies
No Breach of Clause 12.1 (2021 Code) – [Panel no breach ruling upheld at appeal] Requirement to include prescribing information
No Breach of Clause 26.1 (2021 Code) – [Panel no breach ruling upheld at appeal] Requirement to not advertise prescription only medicines to the public
No Breach of Clause 28.1 (2021 Code) – Requirement to publicly disclose certain transfers of value made directly to healthcare organisations located in Europe
No Breach of Clause 28.4 (2021 Code) – Requirement for a transfer of value made to an individual health professional or other relevant decision maker indirectly via a healthcare organisation, to be disclosed once only, preferably as being a transfer to the individual concerned
No Breach of Clause 28.5 (2021 Code) – Requirement for transfers of value to be disclosed on an aggregate basis where recipients of such transfers cannot be identified for legal reasons

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Novo Nordisk: delayed Disclosure UK reporting and weak governance over sponsored third-party materials (AUTH/3763/4/23)

Key facts

What happened

Outcome

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