Astellas: misleading PMCPA submissions about advisory board delegate selection led to public reprimands, audits and ABPI suspension (AUTH/2780/7/15)

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Key facts

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Case	AUTH/2780/7/15
Parties	Anonymous, non-contactable employee v Astellas (Astellas Pharma Europe / Astellas UK)
Issue	False/incomplete and misleading information provided to PMCPA/Appeal Board about advisory board delegate selection criteria; concerns about dismissive senior internal communications
Related case	AUTH/2747/1/15 (Milan meeting arrangements; corrective statement required)
Meeting	Astellas Pharma Europe meeting in Milan, February 2014 (UK attendees involved)
Applicable Code year	2015
Complaint received	08 July 2015
Completed	22 May 2019
Breach clauses	Clause 2 (x2), 9.1 (x2)
Sanctions (headline)	Public reprimands; corrective statements (multiple); audit and repeated re-audits; report to ABPI Board; Astellas UK suspended from ABPI membership (initially 12 months from 24 June, extended to maximum two years; ended 24 June 2018); advertisement listed

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

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An anonymous, non-contactable complainant (appearing to be an Astellas employee) challenged the truthfulness of Astellas’s response to an earlier case about a Milan meeting (Feb 2014) (Case AUTH/2747/1/15).
The earlier response said invitees were selected based on “clinical expertise” and “experience of treating patients with mCRPC”.
The complainant provided internal briefing material indicating affiliates were asked to nominate “mid to top level opinion leaders with the potential to be local product champions” and “data naïve” customers.
The Panel found emails (Sept/Oct 2013) and a Feb 2013 presentation used unacceptable selection criteria (product champions/data-naïve) and were directly relevant to the earlier complaint but were not provided to the PMCPA.
The Panel concluded Astellas provided an incomplete and misleading response in the earlier case and that representatives also misled the Appeal Board about UK sales force involvement in nominations.
The Panel also considered internal communications: a very senior employee’s discussion of the earlier case was perceived by some staff as dismissive; the interview guide used to gather staff feedback was considered biased.
Further investigation (including external counsel) later indicated senior staff knew about the original selection-criteria email during preparation of the earlier response and deliberately omitted it; the Panel described deception and lying by very senior staff.

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Case considered under the 2015 Code.
Breaches ruled: Clause 2 (x2) and Clause 9.1 (x2).
Appeal by Astellas Europe (re “dismissive manner” allegation) was unsuccessful; breaches upheld.
Serious concerns triggered reporting to the Appeal Board, audits and multiple re-audits over several years.
Astellas UK (ABPI member) was suspended from ABPI membership (initially 12 months from 24 June, later extended to the maximum two years), then returned to full membership on 24 June 2018.
Case ultimately completed 22 May 2019; Appeal Board concluded no further action required based on April 2019 re-audit information (while noting it took an extraordinary length of time to reach that point).

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