Employee v Zogenix (AUTH/3567/10/21): Advisory board concerns in Eastern Europe – no breach | PMCPA Case

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Key facts

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Case number	AUTH/3567/10/21
Parties	Employee v Zogenix
Issue	Concerns about arrangements for advisory boards (Croatia, Poland, Hungary), certification, third-party use, and alleged conflicts of interest
Complaint received	4 October 2021
Case completed	11 August 2022
Applicable Code year	2021
Panel decision	No breach of the Code
Clauses considered	2; 5.1; 8.1; 8.2; 19.1; 24.2
Advisory boards took place?	No (none had taken place at time of complaint)
Payments made?	No
Appeal	No appeal

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

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An anonymous, non-contactable employee alleged a senior medical employee planned advisory boards in Croatia, Poland and Hungary despite Zogenix having no presence there, creating inappropriate expectations among HCPs.
Allegations included use of consultants/contractors without sufficient local compliance knowledge, inappropriate certification in Veeva, and signatories not involved in the work.
Further allegations included attempts to influence hourly rates and a conflict of interest via the employee’s partner participating in paid activities.
Additional concerns were raised about a consultant lacking a contract for medical activities and advising non-compliant sponsorship/payments.
Zogenix postponed the Croatia advisory board (scheduled 8 Oct 2021) to conduct an internal investigation; Poland and Hungary were only in early planning and not finalised.
Zogenix provided documentation for the Croatia advisory board (invitation, agenda, advisor selection/honorarium, arrangements) with certification by a final medical signatory; other materials were still in development.
At the time of the complaint, none of the advisory boards had taken place and no payments had been made.

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No breach of the ABPI Code (2021).
The Panel found the complainant did not prove, on the balance of probabilities, that the planned advisory boards would fail Code requirements or that proposed payments would be inappropriate.
The Panel found no evidence that certification was done by the person who developed/drew up the materials (as alleged).
The Panel found the complainant did not establish failures to maintain high standards regarding alleged conflicts of interest, sponsorship/payment issues, or alleged retaliation against consultants.

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