A. Menarini: Broken website links and missing Yellow Card reference on products page (AUTH/2949/3/17)

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Key facts

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Case	AUTH/2949/3/17
Complainant	Hospital doctor
Company	A. Menarini
Issue	Broken website links and missing reference/link to MHRA Yellow Card Scheme on Products/Welcome page; concerns about ability to report adverse events
Medicine mentioned	Adenuric (febuxostat)
Complaint received	24 March 2017
Case completed	7 June 2017
Appeal	No appeal
No breach clauses	Clause 4.9
Breach clauses	Clause 9.1; Clause 26.3
Sanctions	Undertaking received
Panel notes (no ruling)	Concerns raised about Clauses 14.3 and 14.5 (certification/recertification), but no rulings made

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

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A hospital doctor visited A. Menarini’s UK corporate website to find information about, and report, an adverse event relating to Adenuric (febuxostat).
The doctor found multiple broken links (including “Stamp out gout” and a link promising “more information about licensed medicines in the UK”).
The adverse event reporting text on the Products/Welcome page appeared incomplete and the hyperlink to the MHRA Yellow Card Scheme was missing; there were no reporting forms or clear reporting information.
Menarini said the missing Yellow Card and eMC hyperlinks were discovered internally on 31 January 2017 and escalated to the parent company maintaining the site, but the page was not taken down because a company phone number for reporting was present.
The Panel considered the page was accessible to the public (including patients) and introduced a section about the company’s products, so patient-facing side effect reporting requirements applied.

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No breach of Clause 4.9 (the Panel did not accept the complainant had established the website was promotional, so the promotional AE statement requirement did not apply).
Breach of Clause 26.3 (patient-facing material relating to medicines should have included the Yellow Card side effect reporting statement; the reference to the Yellow Card Scheme was missing).
Breach of Clause 9.1 (high standards not maintained due to broken safety-critical links and delayed remediation after internal discovery).
The Panel also expressed concerns about certification/recertification expectations (Clauses 14.3/14.5) but made no rulings on those clauses because the company had not been asked to comment.

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