Pharmacosmos v Vifor: Ferinject ‘QIPP’ conference video ruled promotional, misleading and missing mandatory information (AUTH/2411/6/11)

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Key facts

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Case number	AUTH/2411/6/11
Complainant	Pharmacosmos A/S
Respondent	Vifor Pharma UK Limited
Medicine	Ferinject (ferric carboxymaltose) solution for injection/infusion
Indication (as stated)	Treatment of iron deficiency when oral iron preparations were ineffective or could not be used
Material	Video: “Delivering QIPP by redesigning iron services” (part of NHS Alliance TV News)
Setting	NHS Alliance Annual Conference (Nov 2010); complaint limited to availability to health professionals at the conference
Complaint received	22 June 2011
Undertaking received	17 August 2011
Applicable Code year	2012
Breach clauses	4.1, 4.3, 7.2 (x2)
No breach clauses	9.10, 12.1
Sanctions applied	Undertaking received; Audit of company’s procedures; Recovery of items; Re-audit
Appeal	No appeal. Report by PMCPA to Appeal Board
Case completed	15 November 2012
Notable distribution detail	NHS Alliance sent 990 DVDs including the Vifor film to staff across NHS and government bodies

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

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Pharmacosmos complained about a Vifor Pharma UK video referencing Ferinject (ferric carboxymaltose) shown to health professionals at the NHS Alliance Annual Conference (Nov 2010) as part of “NHS Alliance TV News”.
The video title was “Delivering QIPP by redesigning iron services” and was styled like a news report; Vifor provided speakers, allowed filming at its offices, and internally reviewed/signed off the script.
Vifor’s position was that the video was “service-focused” and non-promotional (QIPP-focused), so it did not include prescribing information.
The Panel found the content became specifically about Ferinject and was promotional in nature; a “Story Outline” document included the key message: “Vifor Pharma want to raise awareness of their product, Ferinject”.
Claims in the video included: “for patients it would mean a speedier recovery” and “The patient can receive all the IV iron they need in just one thirty minute visit”.
The complaint before the Panel was limited to the video being made available to health professionals at the 2010 NHS Alliance Annual Conference (other distribution concerns were noted but not pursued in this complaint).

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No breach of Clause 9.10 (sponsorship was clear from the outset).
No breach of Clause 12.1 (the video was promotional, but its promotional nature was not disguised).
Breach of Clauses 4.1 and 4.3 (missing prescribing information and other obligatory information when Ferinject was promoted).
Breach of Clause 7.2 (misleading claim/implication) in relation to “speedier recovery”.
Breach of Clause 7.2 (misleading implication) in relation to “receive all the IV iron they need in just one thirty minute visit”.
The Panel reported Vifor to the Code of Practice Appeal Board under Paragraph 8.2 of the Constitution and Procedure due to serious concerns about Vifor’s conduct and understanding of the Code.
The Appeal Board required an Authority audit, recovery actions, and re-audits; it raised serious concerns about signatory expertise and senior management oversight.

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