Britannia Pharmaceuticals UK: HCP prep-time payments, missing contracts and weak oversight of investigator-led trials (AUTH/3355/5/20)

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Key facts

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Case	AUTH/3355/5/20
Parties	Contactable ex-employee v Britannia Pharmaceuticals UK
Issues	Payments to HCPs (prep time/FM V; contracts); meetings in India (scope/certification; completeness of prior response); investigator-led clinical trials (SOPs, oversight, patient safety)
Complaint received	22 May 2020
Applicable Code year	2019 (India meetings considered under 2016 Code due to timing)
Breach clauses	2; 9.1; 13.4; 18.1; 23.1; 25.2
No breach clauses	2; 9.1; 14.2
Undertaking received	7 September 2021
Sanctions applied	Undertaking received; Audit of company’s procedures; Advertisement; Public reprimand
Appeal Board consideration dates	1 October 2021; 16 December 2021; 10 March 2022; 15 September 2022; 15 December 2022; 23 February 2023; 14 September 2023
Interim case report first published	24 February 2022
Case completed	14 September 2023
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth3355520-contactable-ex-employee-v-britannia

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

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A contactable ex-employee alleged Britannia paid health professionals (HCPs) above fair market value (FMV), including paying “prep time” even when speakers reused identical or near-identical slide decks, and sometimes paid without contracts.
Britannia reviewed payments (1 Jan 2017–1 Jan 2021) and found issues with contracting and preparation-time payments (including cases where prep time was paid but not warranted).
Separate allegations concerned 2018 meetings in India involving senior Britannia leaders and two UK KOLs/health professionals, said to be promotional and not certified/approved; YouTube videos were cited.
Further allegations stated Britannia lacked appropriate SOPs and governance for investigator-led trials/non-interventional studies, used the MEGS process inappropriately, and did not consider patient safety or involve pharmacovigilance.
The Panel also considered whether Britannia’s earlier response in Case AUTH/3302/1/20 was complete (notably, a second UK HCP contract was not referred to/provided at that time).

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Payments to HCPs: Breaches ruled for unwarranted preparation-time payments (not reflecting FMV) and payments made without fully executed contracts; high standards and Clause 2 issues were also found.
Meetings in India: The Panel ruled the content/certification allegations were out of scope of the UK Code (no UK delegates; India is outside Europe). Therefore, no breach was ruled for Clauses 14.2, 9.1 and 2 regarding the meetings/content. However, Britannia was found in breach of Clause 9.1 for failing to refer to/provide the second UK HCP contract in its response to Case AUTH/3302/1/20.
Investigator-led clinical trials: Breaches ruled due to lack of appropriate approval/supervision processes and failure to consider patient safety (including lack of pharmacovigilance engagement); Clause 2 breach ruled.
The Panel reported Britannia to the Appeal Board due to concerns about procedures (Paragraph 8.2 of the Constitution and Procedure).
The Appeal Board required audits, issued a public reprimand, and required re-audits and progress updates; by September 2023 it concluded significant progress had been made and no further action was required (subject to ongoing completion of work, including nurse service changes).

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