Galderma educational day required delegates to buy Emervel to attend; off-label toxin content and lack of controls led to public reprimand and removal from PMCPA jurisdiction (AUTH/2685/12/13)

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Key facts

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Case number	AUTH/2685/12/13
Parties	Anonymous, non-contactable nurse v Galderma (UK)
Issue	Meeting arrangements; purchase requirement to attend; pecuniary advantage; standards; discredit to industry
Meeting content	Botulinum toxins session comparing products including Azzalure; Pliaglis presentation by Galderma employee; Pliaglis leavepiece available
Purchase/benefit mechanism	Required purchase of minimum two Emervel Classics from named pharmacy; special offer price; free Restylane Skin Booster and “complimentaries”; invoices required for entry
Attendees	39 attendees (list provided by named pharmacy)
Galderma involvement	Venue funded; speakers contacted/paid; flyer/agenda drafted; internal speaker provided; seven staff attended (incl. five sales staff)
Applicable Code year	2012
Breach clauses	Clause 2, Clause 9.1, Clause 18.1
Appeal	Appeal by respondent; Clause 2 breach upheld; appeal unsuccessful
Sanctions	Undertaking received; Advertisement; Public reprimand; Audit required; later removed from list of non-member companies agreeing to comply with the Code; MHRA and ABPI Board informed
Key dates	Complaint received: 12 December 2013; Undertaking (matters not appealed): 6 May 2014; Appeal considered: 15 May 2014; MHRA informed: 4 August 2014; ABPI Board informed: 4 August 2014

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

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What happened

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An anonymous registered nurse complained about an aesthetics “educational day” run with a nurse support group, described in emails as a “Galderma educational day”.
The agenda included content relevant to Galderma prescription-only medicines: a botulinum toxins session comparing products including Azzalure, and a Pliaglis presentation delivered by a Galderma employee; a Pliaglis leavepiece was available.
Attendance was effectively conditional on purchase: members were told there was no meeting charge but they “are required to have purchased a minimum of Two Emervel Classics” from a named pharmacy; non-members paid £40 and also had to purchase two packs.
The covering letter promoted a “special offer” price and stated delegates would receive a “free Restylane Skin Booster and complimentaries”; invoices had to be brought as proof of purchase to gain entry.
Galderma’s involvement included sourcing/funding the venue, drafting the flyer/agenda, contacting and paying speakers, providing an internal speaker, and having seven staff attend (including five sales staff).
There were no written agreements with the nurse support group, co-sponsors, or speakers; arrangements were verbal.
The Panel was concerned that a Galderma employee’s botulinum toxin presentation discussed unlicensed indications (including depression, rosacea and reduction in sweating) and that slides did not appear to have been certified.
After the Appeal Board required an audit and undertaking/assurance, Galderma declined the audit, declined to sign the undertaking/assurance, and stated it no longer accepted PMCPA jurisdiction.

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Outcome

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Breach found (Applicable Code year: 2012).
The Panel ruled breaches of Clause 18.1, Clause 9.1 and Clause 2.
On appeal, the Appeal Board upheld the breach of Clause 2; the appeal was unsuccessful.
The Appeal Board imposed additional sanctions including a public reprimand and required an audit of Galderma’s procedures.
Following refusal to comply with the required undertaking/assurance and audit, the Appeal Board decided to remove Galderma from the list of non-member companies which had agreed to comply with the Code; MHRA and ABPI Board of Management were advised.

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Key facts

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