Roche: Mobile vs desktop webpage certification and alleged off-licence promotion (Kadcyla/Perjeta) – No breach (AUTH/3667/6/22)

📅 2022 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3667/6/22
ComplainantAnonymous, contactable health professional
CompanyRoche Products Ltd
MedicinesKadcyla (trastuzumab emtansine); Perjeta (pertuzumab)
Material/channelRoche Resources website page (Congress and Meetings section), “Future Positive Lite” (ref M-GB-00005336; date of preparation November 2021)
Main issues alleged(1) Mobile vs desktop rendering required separate certification; (2) meeting/video title implied broader HER2+ early breast cancer indications (off-licence promotion)
Applicable Code year2021
Clauses considered2, 5.1, 8.1, 11.2
OutcomeNo breach of the Code
Complaint received26 June 2022
Case completed14 June 2023
AppealNo appeal

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

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What happened

  • A health professional complained about a Roche Resources website page in the “Congresses and Meetings” section (“Future Positive Lite”; ref M-GB-00005336, date of preparation November 2021).
  • Allegation 1: the desktop and mobile versions looked different (desktop showed breadcrumb text “Resources > Congresses and Meetings > Future Positive Lite”; mobile showed a light blue bar instead). The complainant said the two versions should have been certified separately.
  • Allegation 2: a prominent title under the prescribing information—“Tailoring Treatment for Patients with HER-2 positive Early Breast Cancer”—was said to imply Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab) were indicated broadly in HER2+ early breast cancer (i.e., beyond their specific licensed indications).
  • Roche said the site was dynamically responsive; it certified for the primary intended device (desktop) and its SOP required signatories to check other commonly used devices at certification.
  • Roche argued the meeting title described a discussion about tailoring treatment, and the page included prominent links to prescribing information and adverse event reporting, plus contextual “Discussion Topics” and access guidance.
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Outcome

  • No breach of Clause 8.1 (Requirement to certify promotional material).
  • No breach of Clause 11.2 (Requirement not to promote a medicine for an unlicensed indication).
  • No breach of Clause 5.1 (Requirement to maintain high standards) and Clause 2 (Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry) as consequential allegations.
  • No appeal.
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