AUTH/2717/5/14: Roche voluntary admission after MabThera journal advertising appeared on four pages (Clause 6.3)

📅 2014 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2717/5/14
CompanyRoche Products Ltd
ProductMabThera (rituximab) / MabThera subcutaneous (sc)
Material/channelJournal advertising in the British Journal of Haematology (BJH)
Issue/dateMay-II edition (19 May) (bound-in card intended for June-I)
What went wrongTwo separate double-page ads appeared in one issue (covers + bound-in card), resulting in four pages of advertising for the same product
How identifiedVoluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Breach clausesClause 6.3
Applicable Code year2014
Panel findingBreach of Clause 6.3 (company responsible for third parties acting on its behalf)
SanctionUndertaking received
Complaint received23 May 2014
Case completed1 July 2014
AppealNo appeal

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

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What happened

  • Roche voluntarily admitted that an edition of the British Journal of Haematology (BJH) carried advertising for MabThera (rituximab) on four pages.
  • The May-II (19 May) BJH edition contained two separate double-page MabThera advertisements: (1) outside back cover with prescribing information on inside back cover, and (2) a double-sided bound-in card.
  • The bound-in card was intended for the next edition (June-I) but was inadvertently included in the May-II edition by the printing house due to human error.
  • Roche stated both advertisements were separately certified (Clause 14.1) and were never intended to appear together in the same issue.
  • Roche investigated and identified contributing factors at the printer (late arrival of the intended bound-in card, incorrect assumption by a client services representative, and lack of a second check before mass printing/distribution). Publisher checks were online and did not include bound-in items.
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Outcome

  • Breach ruled: the journal bearing advertising for a particular product on more than two pages was a clear breach, and Roche accepted responsibility for third parties acting on its behalf.
  • The Panel ruled a breach of Clause 6.3.
  • No appeal.
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