A Menarini website: failure to certify/recertify public-facing content and preserve certificates (AUTH/2960/6/17)

📅 2017 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/2960/6/17
ComplainantHospital doctor
CompanyA Menarini
IssueCertification/approval governance for company website; failure to certify, re-certify and preserve certificates; Clause 2 concerns including patient safety-related delay regarding missing MHRA Yellow Card link (context from AUTH/2949/3/17)
MaterialCompany website (including link added Jan 2014 to “Firing too quickly” public educational material)
Applicable Code year2016 (with consideration of requirements under earlier Code for initial certification)
Complaint received6 June 2017
Case completed9 August 2017
AppealNo appeal
No breachClause 14.1
BreachClauses 2, 9.1, 14.3, 14.5, 14.6
SanctionsUndertaking received; Additional sanctions: Advertisement

Download the full case report (PDF)


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

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What happened

  • Following an earlier complaint about A Menarini’s corporate website (AUTH/2949/3/17), a hospital doctor raised further concerns about whether the website had been properly certified and re-certified.
  • The complainant questioned how the page could have been approved in July 2011 if it appeared to have been updated later (including a banner/link associated with a 2014 campaign).
  • The complainant also highlighted a patient safety concern from the earlier case: the MHRA Yellow Card Scheme hyperlink had disappeared and, despite being noticed internally, was not corrected until a complaint was received.
  • A Menarini said it had historically used a paper-based approval system and implemented an electronic approval system from January 2016 to improve lifecycle management.
  • A Menarini accepted it failed to review/certify the website appropriately when a link to public educational material (“Firing too quickly”) was added in January 2014, and accepted it had not re-certified or preserved certificates.
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Outcome

  • No breach of Clause 14.1 (the complainant had not established the website was promotional).
  • Breach of Clauses 14.3, 14.5 and 14.6 for failure to certify, re-certify (within two years) and preserve certificates.
  • Breach of Clause 9.1 (failure to maintain high standards) linked to the certification failures.
  • Breach of Clause 2 (bringing discredit upon/reducing confidence in the industry) due to lack of robust certification processes and, separately, the patient safety-related delay around the missing Yellow Card link (as discussed in the earlier case context).
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