Roche: AMD audit reports—patient summary lacked funding disclosure; grant agreement wording also fell short (AUTH/3851/11/23)

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Key facts

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Case	AUTH/3851/11/23
Company	Roche Products Ltd
Complainant	Contactable complainant (health professional)
Issue	Alleged lack of declaration of Roche’s involvement/funding in NOD AMD audit outputs (full report and patient summary)
Materials	NOD AMD Audit Full Annual Report 2023; NOD AMD Audit Patient Summary 2023
Applicable Code year	2021
Complaint received	13 November 2023
Case completed	10 February 2025
Appeal	No appeal
Breach findings	Clause 5.5 (patient summary); Clause 23.2 (agreement wording)
No breach findings	Clause 2; Clause 5.1; Clause 5.5 (full annual report)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A health professional complained about two National Ophthalmology Database (NOD) AMD audit outputs funded by Roche: (1) a full annual audit report and (2) a patient summary.
The complainant alleged Roche’s funding/involvement was not disclosed from the beginning of the full report and not disclosed at all in the patient summary.
Roche said funding was clearly disclosed on the hosting websites and within the full report (foreword and a dedicated “Funding” section), but accepted the patient summary itself did not include a funding statement.
The Panel accepted that website pages disclosed funding, but stressed the downloadable reports needed to “stand alone” with disclosures inside the documents.
The Panel also reviewed the Investigator Initiated Study agreement and assessed whether it met the Code requirements for grant/donation agreements.

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No breach of Clause 5.5 for the full annual audit report: the foreword (page 5) and “Funding” section (page 45, signposted in contents) made Roche’s involvement clear from the start.
Breach of Clause 5.5 for the patient summary: it contained no mention of Roche’s involvement, and could be downloaded and shared without the website disclosure.
Breach of Clause 23.2: the written agreement did not include the required statement that the donation/grant must be clearly acknowledged and apparent from the start.
No breach of Clause 5.1: despite the agreement deficiency, the Panel did not consider Roche failed to maintain high standards.
No breach of Clause 2: the matter did not bring discredit upon or reduce confidence in the industry.
Clause 10.9 was not ruled on because the Panel considered there was no allegation set out regarding it.

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Breach of Clause 5.5 Failing to make sufficiently clear as to the company’s role and involvement
Breach of Clause 23.2 Failing to include, in the written agreement for a donation or grant, a statement that all parties are fully aware that the donation or grant must be clearly acknowledged and apparent from the start
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1 Requirement to maintain high standards at all times
No Breach of Clause 5.5 Requirement to be sufficiently clear as to the company’s role and involvement

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