AstraZeneca advisory board: ‘scientific exchange’ terminology and late-signed consultant contract (AUTH/3514/5/21)

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Key facts

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Case number	AUTH/3514/5/21
Parties	Ex-employee v AstraZeneca
Company activity	Virtual advisory board following ASH 2020 (CLL)
Meeting date	16 December 2020
Steering Committee date	27 November 2020
Congress	American Society of Haematology (ASH) 2020 (5–8 December 2020)
Medicine referenced	Acalabrutinib (Calquence)
Marketing authorisation date noted	5 November 2020 (EMA for 1L and RR CLL)
Advisors	Seven consultant haematology advisors
Applicable Code year	2019
Breach clauses	9.1, 23.1
Sanctions	Undertaking received
Complaint received	24 May 2021
Case completed	9 August 2022
Appeal	No appeal

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

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An ex-employee complained about a post-ASH (Dec 2020) virtual meeting described in documents as a “scientific exchange/debrief”, alleging it was actually a promotional, off-licence advisory board designed to raise awareness of EMA timelines and gather company-directed insights.
AstraZeneca said the activity was a legitimate, non-promotional advisory board (3 hours, virtual) supported by a prior Steering Committee (Nov 2020) to select congress abstracts for discussion in Chronic Lymphocytic Leukaemia (CLL).
AstraZeneca triaged several hundred ASH abstracts to 22; the external Steering Committee selected 14 for the advisory board (3 related to acalabrutinib).
Seven consultant haematology advisors participated; advisors were allocated 2–3 abstracts each to present briefly, with discussion intended to inform AstraZeneca’s medical planning for 2021.
Documentation repeatedly and prominently referred to the meeting as a “scientific exchange meeting” and included phrases such as “partnership between UK clinicians and AstraZeneca” and “HCP-led project”, which the Panel considered potentially misleading for an advisory board where participants were paid.
One Steering Committee advisor’s contract was signed three days after the Steering Committee meeting.

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No breach found for allegations of pre-licence promotion: acalabrutinib (Calquence) had EMA marketing authorisation on 5 November 2020 (before the Steering Committee, ASH 2020, and the advisory board).
No breach found that the meeting was promotional/disguised promotion; therefore no breach for prescribing information or certification requirements.
Breach found for Clause 9.1 due to failure to maintain high standards, driven by frequent/prominent and potentially misleading “scientific exchange” terminology and inconsistent descriptions of the meeting.
Breach found for Clause 23.1 because a written consultant contract was not agreed in advance for one Steering Committee advisor (signed after the Steering Committee).
No breach of Clause 2 (particular censure) despite concerns, as the Panel considered the meeting non-promotional and some documents did describe advisory roles/questions.

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Applicable Code year: 2019
Clauses considered (as listed in case record): 2, 3.1, 4.1, 8.1, 8.2, 9.1, 12.1, 12.2, 14.1, 16.1, 18.1, 23.1, 29
Breach Clause(s): 9.1, 23.1
No breach Clause(s): 2, 3.1, 4.1, 8.1, 8.2, 12.1, 12.2, 14.1, 16.1, 18.1, 23.1 (in relation to selection/number and legitimate need), 29

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