Valneva UK: HCP “partnership” website held promotional for JE vaccine without prescribing information (AUTH/3739/2/23)

📊

Key facts

⌄

Case	AUTH/3739/2/23
Parties	Complainant v Valneva UK Limited
Complaint received	13 February 2023
Case completed	06 March 2024
Applicable Code year	2021
Materials	Valneva in Partnership (VIP) website (homepage and resources page); downloadable JE consumer awareness leaflet (UK-JE-2200002); leaflet download form/consent language
Medicine referenced by Panel	Ixiaro (Valneva’s Japanese encephalitis vaccine)
Main breach	Breach of Clause 12.1 (Failing to include prescribing information) for the VIP website
No breach findings	Clauses 2, 5.1, 8.1, 8.6, 12.1 (leaflet), 12.9, 15.5, 15.6
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

📋

⌄

A health professional complained about Valneva’s “Valneva in Partnership” (VIP) website and a downloadable Japanese encephalitis (JE) consumer awareness leaflet.
The complainant alleged the VIP website was promotional and lacked prescribing information for products mentioned.
The complainant alleged the JE leaflet was promotional (because Valneva had the only vaccine), lacked prescribing information and an adverse event reporting statement, and was likely not properly certified / certificate not retained.
The complainant also alleged the leaflet download form effectively required sign-up to promotional emails and was coercive/against GDPR.
Valneva said the VIP site was aimed at UK healthcare professionals and intended to support travel health services (training/operational support), and that the leaflet was non-promotional disease awareness material developed under MHRA Blue Guide principles.
Valneva acknowledged an error: no opt-out was included in the download journey; it later amended the site so HCPs could download without providing contact details, and stated the collected data had not been used to send promotional materials.

⚖️

⌄

Breach: The Panel found the VIP website (homepage and resources page) promoted Valneva’s JE vaccine (Ixiaro) and breached Clause 12.1 for failing to include prescribing information.
No breach: The Panel did not consider the complainant had established that the JE consumer awareness leaflet was promotional; therefore no breach findings followed for PI/AE statement/disguised promotion/certification allegations.
No breach: No evidence that promotional emails were sent without prior permission; and absent a formal GDPR finding by an appropriate authority, the Panel did not uphold the GDPR-based “high standards” allegation.
No breach: Clause 2 was not upheld because the issue was sufficiently covered by the Clause 12.1 breach.

📖

⌄

Breach of Clause 12.1 Failing to include prescribing information
No Breach of Clause 8.1 Requirement to certify promotional material
No Breach of Clause 8.6 Requirement to preserve certificates
No Breach of Clause 12.1 Requirement to include prescribing information
No Breach of Clause 12.9 Requirement that all promotional material must include the prominent adverse event reporting statement
No Breach of Clause 15.6 Requirement that promotional materials and activities must not be disguised
No Breach of Clause 5.1 Requirement that high standards must be maintained at all times
No Breach of Clause 15.5 Requirement that email must not be used for promotional purposes, except with the prior permission of the recipient
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access