Britannia advisory boards for Apo-Go: poor governance and record-keeping led to Clause 9.1 and 23.1 breaches

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Key facts

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Case	AUTH/3335/4/20
Complainant	Ex-employee
Company	Britannia
Product	Apo-Go (apomorphine hydrochloride)
Therapy area	Parkinson’s disease
Activity type	Advisory board meetings
Number of advisory boards reviewed	6 (January 2019 to February 2020)
Key compliance issues	High standards; advisory board governance; SOP deviations; unclear internal roles; advisor numbers; lack of pre-reading in some cases; paid prep time; missing/insufficient minutes; incomplete document provision to Panel
Applicable Code year	2019
Complaint received	23 April 2020
Case completed	20 April 2021
Panel findings	Breach Clause 9.1; No breach Clauses 23.1, 18.1, 2
Appeal	Complainant appealed no breach of Clauses 23 and 2
Appeal outcome	Breach Clause 23.1 ruled; No breach Clause 2 upheld
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An ex-employee complained that a series of advisory boards about Apo-Go (apomorphine hydrochloride) for Parkinson’s disease, run over ~2 years, were promotional and commercially driven.
Allegations included: marketing/sales organising the meetings; selection of attendees by commercial criteria; limited/no medical presence; outputs shared internally with a “promotional look”; and a wider culture of non-compliance.
Britannia said there was a legitimate need for advice due to new evidence (TOLEDO study) and related EU/US regulatory and launch planning, plus device/service considerations requiring input from different HCP groups (specialists, neurologists, nurses).
The Panel reviewed six advisory boards (Jan 2019–Feb 2020) and raised concerns about: agenda balance (presentation vs discussion), numbers of advisors and staff-to-advisor ratios, lack of pre-reading in some cases despite paid preparation time, lack of chair/staff briefing, and minutes not always being prepared.
On appeal, the Appeal Board focused on deviations from Britannia’s advisory board SOPs (including commercial staff attending as observers without clearly defined roles, and exceeding maximum advisor numbers without proper recording/investigation), and inadequate record-keeping (missing/insufficient minutes) plus incomplete document provision to the Panel (some materials only provided at appeal).

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Breach upheld: Clause 9.1 (high standards) in relation to the advisory boards’ overall arrangements.
Appeal successful: Clause 23.1 breach was ruled by the Appeal Board (consultancy/advisory board requirements not met, including record-keeping).
No breach: Clause 2 (no ruling of particular censure / bringing discredit) was upheld as no breach on appeal.
No breach (Panel): Clause 18.1 was ruled no breach by the Panel; it was not appealed and therefore not considered by the Appeal Board.

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