AUTH/2750/3/15: Actelion v GlaxoSmithKline (Volibris) — interaction charts and “educational grant” wording (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2750/3/15
Parties	Actelion UK and Ireland v GlaxoSmithKline UK
Product	Volibris (ambrisentan)
Therapy area	Pulmonary arterial hypertension (PAH)
Materials	(A) “Endothelin Receptor Antagonists – Drug Drug Interactions” (ref UK/ABT/0023/14); (B) “Stockley’s Drug Interactions Chart” (ref UK/PAH/0031/13)
Audience	Clinicians experienced in PAH in UK adult PAH reference centres
Key issues alleged	Referencing/substantiation for interaction data; completeness/therapeutic value context; ambiguity of promotional vs educational item and Clause 18.4 concerns
Applicable Code year	2014
Clauses considered	7.2, 7.6, 18.4
Decision	No breach
Complaint received	09 March 2015
Case completed	05 June 2015
Appeal	No appeal

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

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Actelion complained about two GlaxoSmithKline UK leavepieces for Volibris (ambrisentan) used with clinicians in UK adult PAH reference centres.
Leavepiece A (ref UK/ABT/0023/14) was a 4-page chart titled “Endothelin Receptor Antagonists – Drug Drug Interactions”, comparing interactions for bosentan (Tracleer), macitentan (Opsumit) and Volibris, with colour-coded interaction status and references shown next to each medicine’s SPC.
Actelion alleged interaction entries for clarithromycin, tacrolimus and ritonavir were unsubstantiated because they could not be found in the Volibris SPC, and argued references should have been provided.
Actelion also alleged the chart was not sufficiently complete to allow readers to form their own opinion of Volibris’ therapeutic value because it focused on interactions.
Leavepiece B (ref UK/PAH/0031/13) was an A5 “Stockley’s Drug Interactions Chart” unfolding to A3, described as produced through an educational grant from GSK and independently produced by Stockley’s editorial team; the reverse included Volibris prescribing information and adverts for Stockley’s publications.
Actelion alleged the Stockley’s chart was ambiguous (educational vs promotional) and that including Volibris prescribing information conflicted with guidance that medical/educational goods and services must not bear a medicine name.

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No breach of Clause 7.6 (references to published studies) for the interaction table.
No breach of Clause 7.2 (sufficiently complete to enable the recipient to form their own opinion of the therapeutic value) for the interaction-focused leavepiece.
No breach of Clause 18.4 (medical and educational goods and services) for the Stockley’s interaction chart leavepiece.
The Panel noted the SPC referencing could give an impression that all interactions were in the Volibris SPC when they were not, and queried whether Clause 7.2 was met in that regard; it requested this be drawn to GSK’s attention (but did not rule a breach).

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