AUTH/2739/11/14: Pfizer/Bristol-Myers Squibb v Daiichi Sankyo – advance budgetary notification and pre-licence promotion risk (edoxaban) | PMCPA Case

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Key facts

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Case number	AUTH/2739/11/14
Complainant	Pfizer (on behalf of Pfizer and Bristol-Myers Squibb)
Respondent	Daiichi-Sankyo UK Ltd
Product / therapy area	Edoxaban (anticoagulant); prevention of stroke in atrial fibrillation (AF) and treatment/secondary prevention of venous thromboembolism (VTE)
Activity	Satellite symposium/workshop framed as “Advance Budgetary Notification” at Pharmacy Management National Forum (Nov 2014)
Main issue	Whether website synopsis/invitation and symposium constituted promotion prior to marketing authorisation; whether ABN requirements (targeting to budget policy decision-makers) were met
Complaint received	14 November 2014
Case completed	24 February 2015
Applicable Code year	2014
Final breach clauses	Clause 3.1 and Clause 9.1
Clause 2	No breach (on appeal)
Sanctions	Undertaking received; additional sanctions not stated

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

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What happened

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Pfizer complained on behalf of itself and Bristol-Myers Squibb (the Alliance) about a Daiichi-Sankyo UK Ltd satellite symposium/workshop at the Pharmacy Management National Forum (18 November 2014) titled as an advance budgetary notification session for a “new oral treatment” (edoxaban) expected in 2015.
The session was advertised on the Forum’s website, which was publicly accessible, with a synopsis stating: “In Quarter 1 of financial year 2015/16, and subject to marketing authorisation approval, Daiichi-Sankyo UK Ltd will be introducing a new oral direct factor Xa inhibitor…”
Pfizer alleged the website synopsis and the proposed symposium promoted edoxaban before marketing authorisation, and that the activity did not meet the strict supplementary requirements for advance budgetary notification (ABN), including targeting only those responsible for making policy decisions on budgets.
Concerns included: broad visibility of the synopsis to non-budget holders; reliance on self-certification/sign-in controls; potential “casual attendance”; and the inclusion of an MSL on the agenda (potentially inviting clinical questions pre-authorisation).
Daiichi-Sankyo argued the Forum audience was payor-focused, that access to workshop details required active selection, and that multiple controls were used (pop-up confirmation of budget responsibility, monitoring registrants, door checks, chairman reminder, and turning away some attendees).
The Panel initially ruled the website and the symposium did not meet ABN requirements and amounted to pre-licence promotion; Daiichi-Sankyo appealed.

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Outcome

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Breach of Clause 3.1 (promotion prior to marketing authorisation) was upheld by the Appeal Board in relation to the website invitation/synopsis because it was not sufficiently targeted solely to appropriate budget decision-makers.
No breach of Clause 3.1 was ruled by the Appeal Board in relation to the symposium itself, given the controls used to ensure only suitably qualified attendees were allowed into the session.
Breach of Clause 9.1 (high standards) was upheld by the Appeal Board, based on posting a blanket invitation on the Forum website without recognising not all delegates were appropriate recipients of ABN information.
No breach of Clause 2 was ruled by the Appeal Board (Panel had ruled a breach, but this was overturned on appeal as Clause 2 is reserved for particular censure and was not warranted on these facts).

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AUTH/2739/11/14: Pfizer/Bristol-Myers Squibb v Daiichi Sankyo – advance budgetary notification and pre-licence promotion risk (edoxaban)

Key facts

What happened

Outcome

Clauses

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