AUTH/3791/7/23: Complainant v Moderna — whistleblowing processes and alleged off-label promotion (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3791/7/23
Parties	Complainant v Moderna
Allegations	Whistleblowing systems/processes inadequate; potential off-label promotion on a Moderna US webcast
Applicable Code	2021
Complaint received	3 July 2023
Case completed	11 December 2024
Appeal	No appeal
Medicine referenced	Spikevax (SPC provided in the case materials)
Event referenced	Moderna US webinar/webcast held 9 September 2021
Key scope point	Panel found complainant did not establish the webcast was within the scope of the ABPI Code
Clauses considered	2, 3.1, 5.1
Outcome	No breach of Clauses 2, 3.1, 5.1
Sanctions	None

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

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An anonymous, non-contactable complainant (self-described health professional) alleged: (1) lack of internal systems/processes to deal with whistleblower complaints; and (2) potential off-label promotion by a Moderna US medical affairs individual on a webcast.
The complainant provided extracts/documents relating to three whistleblower reports made to Moderna in September 2021, including one about a Moderna US webinar held on 9 September 2021.
Moderna stated the webinar was organised by Moderna US with no involvement from Moderna UK; it was intended for a US audience and referenced FDA emergency use authorisation (EUA).
Attendance was reported as over 200 attendees, with only one registered as located in the UK (investigation report: only four attendees from outside the US, including the UK attendee).
Moderna described its whistleblowing (“Speak Up”) arrangements in 2021 (third-party platform) and enhancements introduced in 2022 (new multilingual system, additional channels including a dedicated Europe telephone line), plus Code of Conduct updates effective January 2023.
Moderna provided an investigation report (dated 23 September 2021) concluding the webcast-related whistleblower concerns were unsubstantiated.
Moderna also described investigations into two other September 2021 whistleblowing reports about sharing confidential data; Moderna said it had permission to share the data and corrected a typo (100mcg/50mcg).

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No breach of Clause 2 (Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
No breach of Clause 3.1 (Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation).
No breach of Clause 5.1 (Requirement to maintain high standards at all times).
The Panel found the complainant had not established, on the balance of probabilities, that Moderna lacked whistleblowing systems/processes.
The Panel found the complainant had not established that the US webcast was within the scope of the ABPI Code (and therefore ruled no breach of Clause 3.1).

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