Moderna: Madrid “advisory board” ruled promotional; unlicensed/off-SPC vaccine content and inducement concerns (AUTH/3783/6/23)

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Key facts

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Case number	AUTH/3783/6/23
Company	Moderna Biotech UK Ltd
Meeting/location	Global advisory board, Madrid, Spain (June 2023)
Complainant	Anonymous, non-contactable
UK involvement	One UK HCP attended (selected by Moderna UK)
Scale	56 HCPs from 20 countries; 32 Moderna employees; additional agency/medical writers (number not stated)
Key issues	Advisory board legitimacy; payments/inducement; unlicensed product promotion (mRNA-1345); off-SPC Spikevax booster dose data (100 mcg vs GB SPC 50 mcg); governance/signatory oversight
Applicable Code year	2021
Breach clauses	2, 5.1, 11.1, 11.2, 19.1
No breach clauses	10.1
Complaint received	23 June 2023
Case completed	2 September 2024
Appeal	No appeal; Appeal Board consideration under Constitution and Procedure (19 September 2024 and 28 November 2024)
Sanctions	Undertaking received; additional sanctions not imposed

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

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What happened

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An anonymous complaint alleged a Madrid meeting was effectively a “launch meeting” for off-label RSV and COVID vaccines, rebadged as an advisory board, with luxury travel/hotel and payments.
The meeting (June 2023) was a Moderna global advisory board in Madrid with 56 health professionals from 20 countries; one UK HCP attended (selected by Moderna UK), bringing it under the ABPI Code.
The Panel scrutinised whether it was a genuine advisory board: large numbers (56 HCPs, 32 Moderna employees, plus agency/medical writers), and an advisor-to-company/agency ratio the Panel considered unacceptable.
The agenda included substantial company presentation content; the Panel noted some questions were not answered in the UK table notes, raising concerns about whether meaningful advice was obtained.
Outputs did not meaningfully reflect the stated need for country/regional differences, undermining the rationale for a large global advisory board.
Because the Panel did not consider it a genuine advisory board, payments to HCPs were treated as fees to attend a promotional event.
Meeting content included an investigational product (mRNA-1345) and Spikevax booster clinical data using 100 mcg, inconsistent with the Great Britain Spikevax SPC booster dose of 50 mcg.
Hospitality allegations focused on hotel/travel; the UK HCP flew economy, stayed in a 4* business hotel, and travel timing was the night before and morning after.
Moderna UK acknowledged governance gaps: overseas travel for the UK HCP was not certified and meeting materials were not examined by ABPI signatories (per its own policy).

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Outcome

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Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 11.1 Promoting a medicine prior to the grant of its marketing authorisation
Breach of Clause 11.2 Promoting a medicine in a manner inconsistent with its summary of product characteristics
Breach of Clause 19.1 Provision of a pecuniary advantage or benefit to a health professional in connection with the promotion of medicines or as an inducement to prescribe, supply, administer and/or recommend a medicine
No breach of Clause 10.1 Requirement that companies must not provide inappropriate hospitality
Appeal Board: very concerned; considered additional sanctions but decided none were required.

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Clauses

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Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 Failing to maintain high standards
Clause 10.1 Requirement that companies must not provide inappropriate hospitality (No breach)
Clause 11.1 Promoting a medicine prior to the grant of its marketing authorisation
Clause 11.2 Promoting a medicine in a manner inconsistent with its summary of product characteristics
Clause 19.1 Provision of a pecuniary advantage or benefit to a health professional in connection with the promotion of medicines or as an inducement to prescribe, supply, administer and/or recommend a medicine

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Moderna: Madrid “advisory board” ruled promotional; unlicensed/off-SPC vaccine content and inducement concerns (AUTH/3783/6/23)

Key facts

What happened

Outcome

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