AUTH/3789/7/23: Complainant v Moderna — e-consent proposal and proactive scientific communications (No breach)

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Key facts

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Case number	AUTH/3789/7/23
Parties	Complainant v Moderna
Issue	Allegations regarding e-consent and communications (regional proposal to seek HCP consent; alleged proactive preprint sharing/off-label risk)
Applicable Code	2021
Complaint received	3 July 2023
Case completed	11 September 2024
Appeal	No appeal
Material referenced	Presentation dated November 2021: “E-concent management – Manual process” (4 slides)
Panel finding	No breach of Clauses 2, 3.1, 5.1, 5.6, 15.5, 15.6
Additional sanctions	Not stated

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

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An anonymous, non-contactable complainant submitted a November 2021 presentation titled “E-concent management – Manual process”.
The presentation described a regional proposal for obtaining HCP opt-in/opt-out to receive “scientific, medical information”, including a proactive call script and a confirmatory opt-in email.
The complainant alleged Moderna would be proactive in communicating non-peer-reviewed preprint data and that the process gave “carte-blanche” to send any data, potentially leading to off-label promotion.
PMCPA asked Moderna to consider Clauses 2, 3.1, 5.1, 5.6, 15.5 and 15.6 (2021 Code).
Moderna said the presentation pre-dated Moderna UK joining the ABPI (joined January 2023), that Moderna UK did not create the presentation, and that neither the presentation nor the described process was used in the UK.
Moderna stated that in the UK it would obtain prior permission before sending digital communications and that it did not send promotional digital communications directly to UK HCPs (distribution via third parties with appropriate consents).
The Panel noted some ambiguity in the presentation footnotes referencing “page 10” and “page 11” (content unclear to the Panel).

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No breach of the ABPI Code of Practice (2021) was found.
The Panel considered jurisdiction case-by-case given the activity pre-dated ABPI membership, and noted UK companies can be responsible for overseas affiliates’ acts/omissions within scope of the Code.
On the balance of probabilities, and based on limited information, the Panel did not accept that the presentation meant Moderna could send any data it wished, nor that Moderna had proactively communicated preprint data as alleged.

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