Anonymous Employees v Otsuka Europe (AUTH/3174/3/19): Disguised promotion at congress and internal “don’t complain” messaging

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Key facts

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Case	AUTH/3174/3/19
Parties	Anonymous Employees v Otsuka Europe
Applicable Code year	2016
Complaint received	20 March 2019
Case completed	16 October 2019
Key activities	2018 ERA-EDTA Congress symposium (Copenhagen) and internal management update meeting (18 March 2019)
Product referenced	Tolvaptan (Jinarc)
Breach clauses	Clause 2; Clause 9.1; Clause 12.1
Sanctions	Undertaking received; Advertisement
Notable “no breach” point	Allegation about training staff to give “appropriate answers” for the audit: no breach (outside scope of the Code)
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth3174319-anonymous-employees-v-otsuka-europe

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

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Anonymous employees alleged international meetings were being misclassified and certified as non-promotional despite being promotional, allegedly to increase attendance.
Example cited: an Otsuka-sponsored symposium at the 2018 ERA-EDTA Congress (Copenhagen, 24–27 May 2018) which was coded as non-promotional in Otsuka Europe’s approval system but contained multiple references to tolvaptan (Jinarc).
Materials advertising the symposium referred to discussing ERA-EDTA guidelines on ADPKD and did not mention tolvaptan, which the Panel considered could mislead some HCPs about the promotional nature of the session.
Otsuka Europe’s investigation found the symposium slides were approved as promotional by the Danish affiliate, and Otsuka Europe also had a promotional booth for Jinarc at the congress.
Separately, employees complained about comments at an internal weekly management update meeting (18 March 2019) where a senior employee allegedly asked staff to pledge not to complain about individuals/departments for six months and made comments that could be interpreted as discouraging external complaints/whistleblowing.
An additional allegation that staff would be trained to give “appropriate answers” to the PMCPA during an upcoming audit was considered; the Panel found this aspect was outside the scope of the Code and ruled no breach on that point.

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International meetings (ERA-EDTA symposium):
- Breach of Clause 9.1 (failure to maintain high standards) for misclassifying a clearly promotional symposium as non-promotional.
- Breach of Clause 12.1 (disguised promotion) because not all HCPs would have expected the symposium to be promotional based on the advertising materials.
- Initially, the Panel ruled no breach of Clause 2 for this element; the complainants appealed and the Appeal Board ruled a breach of Clause 2 (organisational failure to understand promotional vs non-promotional activities reduced confidence in the industry).
Internal meeting (18 March 2019):
- Breach of Clause 9.1 (high standards) as the comments could be interpreted as discouraging complaints outside the company.
- Breach of Clause 2 because the implied message ‘do not complain outside the company’ was considered serious and undermining of self-regulation, bringing discredit on and reducing confidence in the industry.
- No breach in relation to the allegation about training staff to give “appropriate answers” during the audit (Panel considered the subject matter outside the scope of the Code and noted audit preparation training is not inappropriate).

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