GSK satellite symposium invitation at ESC 2009: not disguised promotion, but missing prescribing information (AUTH/2264/9/09)

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Key facts

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Case	AUTH/2264/9/09
Parties	Anonymous complainant v GlaxoSmithKline (UK) Limited
Material	Invitation to a satellite symposium at ESC Congress 2009
Event	“Living with PAH – Challenges and Options” (Barcelona, 2009)
Medicines referenced	Flolan (epoprostenol) and Volibris (ambrisentan)
Main issue	Whether the invitation was disguised promotion and whether it required prescribing information
Applicable Code year	2008
Complaint received	10 September 2009
Case completed	22 October 2009 (PDF) / 27 October 2009 (web page)
Appeal	No appeal
Breach clauses	Clause 4.1
Non-breach findings	Clause 12.1 (no disguised promotion); Clause 2 (no breach)
Other clause noted	Clause 4.10 (Panel view: should include date of preparation; no ruling)
Sanction	Undertaking received

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

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An anonymous complainant (“Unhappy Physician”) picked up an invitation from GlaxoSmithKline’s exhibition stand at the European Society of Cardiology (ESC) Congress, Barcelona 2009, to a satellite symposium: “Living with PAH – Challenges and Options”.
The complainant alleged the session was disguised promotion for Flolan (epoprostenol) and Volibris (ambrisentan), and said the third talk was “simply full of Volibris data”.
The complainant said the invitation looked disease-focused and should have made clearer that product information would be presented so they could choose not to attend.
The complainant also alleged the invitation lacked prescribing information, had no date, and used colours similar to the Volibris logo.
GSK stated the invitation and other materials clearly stated the symposium was organised/sponsored by GSK; the agenda included “Long-Term Treatment with Ambrisentan: FCII and CTD”.
GSK said attendees received an abstract/biographies booklet (placed on seats/available at entrance) which included prescribing information and declarations of GSK’s involvement.
The Panel considered applicability of codes: the symposium was organised from the UK and held in Spain, so both UK and Spanish codes applied (per supplementary information to Clause 1.7).

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No breach of Clause 12.1 (disguised promotion): the invitation made sponsorship clear and explicitly referenced a presentation of long-term ambrisentan data.
Breach of Clause 4.1: because the invitation referred to ambrisentan and its use in PAH, it was “in effect” promotional material for Volibris and should have included prescribing information.
No breach of Clause 2: despite the Clause 4.1 breach, the Panel did not consider high standards had not been maintained to the level warranting Clause 2 censure.
Date issue: the Panel considered the invitation should have included a “date of preparation” (Clause 4.10), but made no ruling because GSK had not been asked to respond under that clause; the Panel requested the company be advised of its view.

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