AbbVie v Piramal: Sevoflurane “drop test” leaflet ruled promotional and missing mandatory information (AUTH/2815/12/15)

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Key facts

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Case number	AUTH/2815/12/15
Parties	AbbVie v Piramal Healthcare UK Ltd
Material	Leaflet detailing a drop test of Sevoflurane Piramal screw-top glass bottles (ref MKT-SEV-025)
Product	Sevoflurane (Sojourn Sevoflurane 100% Inhalation Vapour Liquid, UK PL 29595/0002)
Main issue	Leaflet deemed promotional; missing cost, AE reporting statement, and date of preparation/last revision
Complaint received	22 December 2015
Case completed	6 May 2016
Applicable Code year	2015
Breach clauses	4.1, 4.9, 4.10, and 9.1
No breach clauses	2
Appeal	No appeal
Sanctions	Undertaking received

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

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AbbVie complained about a Piramal leaflet describing a “drop test” of Sevoflurane Piramal screw-top glass bottles (ref MKT-SEV-025), used at a European conference and also used with customers and internally in the UK.
AbbVie alleged the leaflet was promotional and omitted mandatory items: cost, date drawn up, and the adverse event reporting statement; AbbVie also alleged failure to maintain high standards and that omission of AE reporting prejudiced patient safety (Clause 2).
Piramal argued the leaflet was not promotional because it focused on packaging robustness rather than clinical safety/efficacy, and said it had been withdrawn from use/external distribution in November 2015 (though this was not made clear during inter-company dialogue).
The Panel considered that packaging is part of the medicine and could influence choice; therefore claims about packaging (including reference to a 5-year shelf life) fell within promotion.

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The leaflet was ruled to be promotional and therefore subject to the Code.
Breach ruled for missing cost information (as part of prescribing information requirements): Clause 4.1.
Breach ruled for missing adverse event reporting statement: Clause 4.9.
Breach ruled for missing date of preparation/last revision: Clause 4.10.
Breach ruled for failure to maintain high standards: Clause 9.1.
No breach of Clause 2 (Panel considered an additional Clause 2 ruling disproportionate in the circumstances).

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