GW Pharmaceuticals: meeting hospitality and pre-licence Epidiolex slide deck allegations (AUTH/3029/4/18) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/3029/4/18
Company	GW Pharmaceuticals
Complainant	Contactable complainant (identity not known to the Panel)
Product	Cannabidiol (Epidiolex) (unlicensed at the time)
Main issues	Hospitality at lunch meeting; alleged pre-licence promotion; alleged solicitation; amended slides and certification
Hospitality cost	£35.35 for three persons (approx. £11.80 for the HCP attendee, per GW)
Panel decision	No breach
Applicable Code year	2016
Clauses considered	2; 3.1; 9.1; 14.1; 15.2; 22.1
Complaint received	5 April 2018
Case completed	21 December 2018
Appeal	No appeal
Notes	Panel referenced reliance on Clause 1.2 exemption for unsolicited requests; no ruling made on Clause 15.9 as no allegation was considered to arise.

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

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A contactable complainant alleged that a third-party employee acting for GW Pharmaceuticals took a named health professional to lunch at a local café and that the discussion was unrelated to epilepsy, with no educational content.
The complainant alleged the health professional was not a relevant customer (said to not treat epilepsy/paediatric epilepsy) and that paying for lunch was inappropriate hospitality.
The complainant also alleged pre-licence promotion of cannabidiol (Epidiolex) at a hospital presentation in February 2018, claiming the meeting was solicited and therefore promotional before marketing authorisation.
The complainant further alleged the slide deck had been approved but then amended before the meeting and, because the amended version was not certified, this breached the Code.
Epidiolex was unlicensed at the time; GW stated a marketing authorisation application had been submitted on 29 December 2017 for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome.
GW provided statements and supporting materials (including emails and a contemporaneous photograph) and argued: (a) the health professional was relevant; (b) the lunch discussion was largely scientific; (c) the February presentation was in response to an unsolicited request and was non-promotional; and (d) the slides did not require certification because the activity fell under the unsolicited request exemption.

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No breach of the Code was found.
The Panel found the health professional was a relevant health professional and GW had not failed to maintain high standards in this regard.
On hospitality, the Panel noted governance concerns (public venue, lack of formal agenda) but concluded the complainant had not established, on the balance of probabilities, that there was no educational content.
On the February 2018 presentation, the Panel concluded GW could rely on the Clause 1.2 exemption (unsolicited requests) and therefore the presentation did not promote Epidiolex prior to licence.
On amended slides and certification, the Panel accepted that where the unsolicited request exemption applied, certification was not required and ruled no breach.
No ruling was made in relation to Clause 15.9 (briefing material) because the Panel did not consider there was an allegation in that regard.

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