Otsuka criticised for lack of transparency in PMCPA submission about earlier case (AUTH/3757/3/23)

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Key facts

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Case number	AUTH/3757/3/23
Parties	Complainant v Otsuka
Issue	Allegations about Otsuka’s submission in relation to a previous case (AUTH/2752/3/15)
Applicable Code year	2015
Complaint received	31 March 2023
Case completed	15 April 2024
Appeal	No appeal
Breach clauses	Clause 2; Clause 9.1 (x2)
No breach clauses	Clause 2 (x2); Clause 9.1
Sanctions applied	Undertaking received; Advertisement
Panel highlights	Self-regulation relies on full and frank disclosure; lack of transparency was of considerable concern; witness statements did not reflect full interview content; witnesses not shown final statements and statements not signed.

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

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A named ex-employee complained about Otsuka’s submission to the PMCPA in an earlier case completed in 2015 (Case AUTH/2752/3/15).
The complainant alleged Otsuka failed to disclose relevant information to the PMCPA, did not allow witnesses to see/sign final statements (and removed information), and that three employees were forced out for being perceived as whistleblowers.
Otsuka initially said it could not locate its 2015 response materials due to the passage of time and personnel changes; it initially denied wrongdoing.
After the PMCPA provided a scanned copy of Otsuka’s original 2015 submission, Otsuka located additional HR investigation materials held in Otsuka Pharmaceuticals Europe Ltd HR files.
Otsuka acknowledged that relevant information discussed in interviews (including prior internal awareness of the incident before the PMCPA complaint) was not included in the witness statements submitted in 2015.
The Panel compared 2015 witness statements with interview transcripts/audio and found the statements did not reflect the full content of the interviews.
The Panel also found processes were not robust: interviewees were not given the opportunity to agree and sign the witness statements; statements were unsigned and there was no evidence witnesses saw final versions.
On the whistleblowing/“pushed out” allegation, the Panel noted its role was limited to the Code and found the complainant had not established unfair treatment in the absence of a formal finding.

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Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry (failure to include relevant information / lack of transparency in the 2015 submission).
Breach of Clause 9.1 (x2) Failing to maintain high standards (i) omission of important information from the 2015 submission; (ii) failure to have robust processes for witness statements to be agreed/signed.
No Breach of Clause 2 (x2) Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (including no definitive evidence that information was “removed” from statements; and no breach found regarding alleged whistleblower retaliation).
No Breach of Clause 9.1 Requirement to maintain high standards (in relation to the allegation that employees were forced out as whistleblowers).
No appeal.

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