Roche: patient organisation website grant—support not clear from the outset and grant agreement missing required transparency wording

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Key facts

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Case	AUTH/3676/7/22
Parties	Complainant v Roche
Issue	Allegations about content on a patient organisation website; transparency of grant support and robustness of grant agreement; alleged public promotion of Hemlibra
Applicable Code	2021
Complaint received	07 July 2022
Case completed	28 February 2024
Appeal	Appeal by the respondent (Roche)
Breach clauses	Clause 23.2; Clause 25.3
No breach clauses	Clause 2; Clause 5.1; Clause 6.5; Clause 12.1; Clause 26.1; Clause 26.2
Medicine mentioned	Hemlibra (emicizumab)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A whistleblowing complainant raised concerns about Roche’s internal compliance procedures and a patient organisation website that had been supported by a grant (grant dated November 2020).
The complainant alleged Roche’s support was not clear “from the outset” on the website; the involvement statement was said to be hidden at the bottom of pages and often only logos appeared.
The complainant alleged the grant agreement was not robust enough to ensure the declaration of support would be visible from the start of webpages.
The complainant also alleged two articles on the website promoted Hemlibra (emicizumab), a prescription only medicine, to the public and to health professionals without prescribing information; and that the word “new” was used inappropriately in one article.
Roche said it had no involvement in creating/approving the patient organisation website content; the two Hemlibra-related articles pre-dated the grant (July 2018 and July 2019). For one article, Roche said it had provided information reactively on request, but had no visibility of how it was used.
The Panel and Appeal Board focused on whether the declaration of Roche’s involvement was sufficiently clear at the outset (it appeared after scrolling down several screens to the footer) and whether the written agreement contained the required transparency statement for patient organisation grants.

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Breach of Clause 25.3 (upheld on appeal): sponsorship/support was not clearly acknowledged from the outset; declaration placement meant users could miss it.
Breach of Clause 23.2 (upheld on appeal): written agreement for the grant did not include the required statement that the grant must be clearly acknowledged and apparent from the start.
No breach of Clause 5.1 (x2) (appeal successful): Appeal Board overturned the Panel’s two breach rulings of Clause 5.1.
No breach of Clauses 2, 6.5, 12.1, 26.1, 26.2 in relation to the two Hemlibra-related articles (the complainant did not establish Roche was responsible for the content).

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