Roche: Ocrevus infusion webpage alleged to mislead on monitoring and dedicated line (AUTH/3827/9/23)

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Key facts

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Case	AUTH/3827/9/23
Company	Roche
Complainant	Anonymous, non-contactable complainant (self-described health professional)
Product	Ocrevus (ocrelizumab)
Material	Promotional webpage (part of Ocrevus promotional website) with an infusion schedule timeline graphic
Main allegations	Graphic implied only 1 hour monitoring; omission of “dedicated line” administration detail; alleged patient safety risk
Applicable Code	2021
Clauses considered	2; 5.1; 6.1 (x2)
Outcome	No breach of Clause 2; No breach of Clause 5.1; No breach of Clause 6.1 (x2)
Complaint received	22 September 2023
Case completed	30 July 2024
Appeal	No appeal

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

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An anonymous, non-contactable complainant (self-described health professional) complained about a Roche promotional webpage about Ocrevus infusion schedules.
The complainant alleged the graphic was misleading because it showed an “Observation” step of “1hr”, which they said could imply monitoring was only for one hour rather than during the entire infusion and for at least one hour after.
The complainant also alleged the webpage omitted that Ocrevus should be administered through a dedicated line, creating potential patient safety risk.
The PMCPA asked Roche to consider Clauses 6.1, 5.1 and 2 of the 2021 Code.
Roche argued the graphic was a high-level summary of infusion suite occupancy/time savings for prescribing HCPs, not a full administration guide; and that the specialist setting and intended audience would understand monitoring and dedicated line requirements.

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No Breach of Clause 6.1 (x2) Requirement that information must not be misleading.
No Breach of Clause 5.1 Requirement to maintain high standards at all times.
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry.
No appeal.

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