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PMCPA Case

AUTH/3013/1/18: AstraZeneca employee complaint—uncertified global advisory board and incomplete/inaccurate information to PMCPA

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/3013/1/18
PartiesAstraZeneca employee v AstraZeneca
Applicable Code year2016
Core issuesGlobal Code training allegations; global advisory board arrangements; failure to certify; provision of incomplete/inaccurate information to PMCPA
ActivityGlobal Dapagliflozin T1D Indication Advisory Board (Amsterdam, 10 November 2017) relating to Forxiga (dapagliflozin) and DEPICT-1/-2
Advisors / internal attendees16 external advisors; 12 AstraZeneca staff (plus third-party agency staff) (as described in case materials)
Complaint received22 January 2018
Undertaking received10 April 2018
Panel reconvened2 May 2019
Appeal Board consideration11 July 2019
Case completed11 July 2019
PublicationUpdated case report (including addendum) published 3 February 2020; reprimand published in May 2020 Review (see also May 2018 Review)
Breach clausesClause 9.1; Clause 14.2
No breach clausesClause 2; Clause 16.1; Clause 18.1; Clause 23.1
SanctionsUndertaking received; Public reprimand (additional sanctions); no further action (audit considered but not required)

Download the full case report (PDF)

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

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What happened

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  • An anonymous, non-contactable complainant (described as an AstraZeneca UK marketing company employee) alleged AstraZeneca’s global functions did not receive appropriate ABPI Code training and that globally led activities often did not comply.
  • The complainant referred to a global advisory board in 2017 with “over 15 external advisors and a similar number of AstraZeneca employees”, alleging the UK nominated signatory initially refused approval and was then put under pressure to approve.
  • AstraZeneca assumed the meeting was the Global Dapagliflozin T1D Indication Advisory Board held in Amsterdam on 10 November 2017 (Forxiga/dapagliflozin; DEPICT-1 and DEPICT-2).
  • The meeting involved 16 external advisors (including 2 from the UK) and 12 AstraZeneca staff; the Panel raised concerns about the number of internal attendees, late submission for local review (12 working days before), and last-minute changes.
  • The advisory board involving UK health professionals was not certified before it commenced (AstraZeneca said this was due to timing and avoiding retrospective certification).
  • During the case, the Panel found AstraZeneca’s description of what happened (especially internal attendance arrangements) was incomplete and only clarified after requests for further information.
  • After the case concluded, additional information (an internal email trail dated 7–8 November 2017) was provided to PMCPA, raising concerns about compliance culture and whether AstraZeneca had provided complete and accurate information in its response.
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Outcome

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  • No breach of Clause 16.1 (training allegations not proven on the balance of probabilities).
  • Breach of Clause 14.2 (failure to certify the advisory board involving UK delegates).
  • No breach of Clauses 23.1 and 18.1 (complainant did not show the advisory board was not genuine / payments inappropriate on the balance of probabilities).
  • Breach of Clause 9.1 (short time frame and certification arrangements increased pressure on UK certifiers; failure to certify meant high standards not maintained).
  • No breach of Clause 2 (Panel did not consider circumstances warranted particular censure).
  • Following further consideration, the Appeal Board required a public reprimand for failing to provide complete and accurate information in an open and transparent way.
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