Britannia Pharmaceuticals: failure to disclose investigator-led trials and poor documentation (AUTH/3490/3/21)

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Key facts

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Case number	AUTH/3490/3/21
Company	Britannia Pharmaceuticals Ltd
Issue	Failure to publish details about certain investigator-led trials; lack of required documentation
How it started	Voluntary admission treated as a complaint under Paragraph 5.6 of the Constitution and Procedure
Complaint received / voluntary admission received	15 March 2021
Case completed	8 August 2021
Applicable Code year	2019
Trials/studies referenced	Nine investigator-led trials (interventional and non-interventional); payment dates 2017–2019 for eight; unknown for ninth
Panel findings	Breach Clause 9.1; No breach Clause 2; No ruling on Clauses 13.1 and 13.3 due to insufficient information
Sanctions	Undertaking received
Appeal	No appeal

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

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What happened

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In responding to another PMCPA case (AUTH/3355/5/20), Britannia Pharmaceuticals Ltd made a voluntary admission that it had failed to publish details about certain investigator-led trials.
Under Paragraph 5.6 of the Constitution and Procedure, the Director treated the voluntary admission as a complaint and took the matter up with Britannia.
Britannia conducted an internal review of all investigator-led trials (interventional and non-interventional) funded by the company and acknowledged they were not appropriately disclosed.
Britannia said the payments for these studies had historically been processed as medical and educational goods and services (MEGS) and disclosed as transfers of value, but the studies themselves were not disclosed on the company website or clinical trial registries/databases as required.
Britannia identified that its clinical trial SOPs were not active; SOPs in force until 2018 became obsolete after trials completed and staff left, and investigator-initiated research administration was not absorbed.
Britannia attempted to reconcile study details with study centres (emails in June and July 2021) but received only one response.
One of the nine studies involved funding paid in 2019 to an overseas disease association for a study that had not yet commenced (MEGS contract provided in 2020); the Panel noted concern about the delay between funding and commencement.
Britannia implemented an SOP for Investigator Initiated Research Trials (receipt, review, approval, tracking and management) and recorded employee acknowledgements; it also stated it would not consider further studies for funding until SOPs/processes were effective.

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Outcome

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Breach ruled: Clause 9.1 (failure to maintain high standards) due to lack of required documentation (including around payments) and inability to determine if/which trial results required disclosure.
No breach ruled: Clause 2 (Panel was extremely concerned but did not have sufficient information to apply this particular censure).
No ruling made: Clauses 13.1 and 13.3 (insufficient information to determine which studies fell under which clause, whether results required disclosure, and who the sponsor responsible for disclosure was).
For the study that had not commenced, the Panel noted that if there were no details to disclose, there could be no breach in that regard.

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