Pharmaxis: CML journal miscategorised and materials not certified in final form (AUTH/2643/10/13)

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Key facts

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Case	AUTH/2643/10/13
Parties	Anonymous complainant v Pharmaxis
Issue area	Approval/certification of material; categorisation of CML journal; training/ABPI exam allegation
Medicines mentioned	Bronchitol (mannitol); Osmohale (mannitol)
Complaint received	1 October 2013
Case completed	19 February 2014
Applicable Code	2012
Appeal	Yes — by complainant (on Clause 16.4); unsuccessful
Breach clauses	2, 9.1, 14.1, 14.3 (x3)
No breach clauses	2, 9.1, 14.3, 14.6, 15.9, 16.1, 16.4 (and no breach of Clause 3.1 on the narrow pre-launch point considered)
Sanctions	Undertaking received; Advertisement
Core learning	Misclassification and inconsistent handling of sponsored educational materials (MEGS vs promotional) plus failure to certify final form can escalate to Clause 2.

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

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An anonymous complainant (contractor to client) alleged weaknesses in Pharmaxis’ approval/certification systems and Code training.
Pharmaxis marketed Bronchitol (mannitol) for cystic fibrosis (UK launch 1 June 2012) and Osmohale (mannitol) diagnostic (UK launch Dec 2007).
The complaint focused on (1) lack of an SOP/process for non-promotional items and (2) a cystic fibrosis journal, Current Medical Literature (CML), which Pharmaxis sponsored and distributed.
CML was produced by an independent publisher/editorial board and supported by an educational grant; Pharmaxis was sole sponsor/distributor and placed a single-page advertisement in each edition.
Some CML editions were treated as promotional (and certified) while others were treated as non-promotional (and not certified), creating inconsistent categorisation.
The Panel reviewed CML Volume 3 No.1 (post-authorisation Bronchitol ad; before updated certification process) and Volume 3 No.2 (same ad; after updated process), plus a pre-launch issue (Volume 1 No.1, 2011) with a corporate advert.
An external consultant audit (requested by Pharmaxis) found that before Aug 2013 items were not certified in their final form (certification occurred at final artwork stage rather than final form).
Training allegations included that staff were out of touch with the Code and that a junior product manager/marketing support officer did not have ABPI exam accreditation; this point was appealed by the complainant.

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Breach found: Clause 14.3 (x3) in relation to CML (failure to certify as required and mis-handling of MEGS vs promotional status).
Breach found: Clause 14.1 (promotional material not certified in final form pre-Aug 2013).
Breach found: Clause 9.1 (high standards not maintained).
Breach found: Clause 2 (conduct reduced confidence/brought discredit due to poor understanding/categorisation and certification failures).
No breach: Clause 14.3 for the broad, general allegation about other non-promotional materials (excluding CML).
No breach: Clause 3.1 (pre-launch CML issue did not directly/indirectly promote Bronchitol before marketing authorisation) on the narrow point considered.
No breach: Clause 14.6 (failure to preserve certificates not proven).
No breach: Clause 15.9 (representatives’ briefing material) — Panel noted it would have been helpful to brief reps on request-card distribution, but no breach ruled given the allegation/clauses in play.
No breach: Clauses 16.1 and 16.4 (training/ABPI exam). The Appeal Board upheld no breach of Clause 16.4 on the narrow ground that the complainant provided no specific evidence the employee met the definition of a representative.

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