Napp Pharmaceuticals: Norway meeting for UK HCPs to discuss Remsima switching ruled an inducement (AUTH/2795/9/15)

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Key facts

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Case number	AUTH/2795/9/15
Complainant	Anonymous, non-contactable ‘NHS whistleblower’
Company	Napp Pharmaceuticals Limited
Medicine	Remsima (infliximab), biosimilar of Remicade
Activity 1	Promotional meeting for UK HCPs held in Norway (‘Norway IBD exchange’), 11–13 October 2015
Activity 2	Switching leavepiece: ‘Your guide to changing treatment Remicade → Remsima’ (ref UK/REMS-15078)
Hospitality/cost noted	Average total cost of hospitality including air fares: £799.73 per person
Panel findings (meeting)	Breach Clause 22.1 (no clear and cogent reason to meet outside UK); breach Clause 18.1 (inducement); breach Clause 9.1 (high standards); breach Clause 2 (later overturned)
Appeal outcome	Breaches of Clauses 22.1, 18.1, 9.1 upheld; Clause 2 overturned (no breach)
Leavepiece outcome	No breach of Clauses 2, 7.2, 7.9, 7.10, 9.1
Complaint received	18 September 2015
Case completed	14 March 2016
Applicable Code year	2015
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous, non-contactable ‘NHS whistleblower’ complained about Napp’s promotion of Remsima (infliximab), a biosimilar of Remicade, focusing on: (1) a UK HCP meeting held in Norway and (2) a switching leavepiece.
The meeting (‘Norway IBD exchange’, Oslo, 11–13 October 2015) was a Napp-organised promotional meeting for UK health professionals, including hospital tours and sessions on initiating/switching to Remsima.
The Panel considered the meeting was organised specifically with a focus on Remsima and to promote switching from Remicade to Remsima in IBD, and that invitees were selected for their ability to influence Remsima decisions.
The Panel and Appeal Board found there was no “clear and cogent reason” to hold the meeting outside the UK; hospital tours were viewed as not integral and appeared to help justify the overseas venue.
Average total cost of hospitality (including air fares) was stated as £799.73 per person; hospitality itself was not found excessive, but the overseas venue without clear justification was key.
The leavepiece (‘Your guide to changing treatment Remicade → Remsima’, ref UK/REMS-15078) described eligibility for switching, case-by-case switching, what to expect after switching, and included prescribing information and additional safety information (TB risk).

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Meeting in Norway: Breaches ruled for Clause 22.1, Clause 18.1 and Clause 9.1. A Panel breach of Clause 2 was overturned on appeal (no breach of Clause 2 on balance).
Switching leavepiece: No breach of Clauses 2, 7.2, 7.9, 7.10 and 9.1.

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