AUTH/3024/3/18: Anonymous hospital consultant v GW Pharmaceuticals (Epidiolex) – no breach (unsolicited request exemption) | PMCPA Case

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Key facts

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Case	AUTH/3024/3/18
Complainant	Anonymous, non-contactable hospital consultant (described as consultant neurologist)
Company	GW Pharmaceuticals
Medicine / subject	Epidiolex (cannabidiol); referred to as cannabidiol/CBD in company materials
Allegation	Pre-licence promotion at a hospital meeting (February 2018)
Regulatory status at time	Marketing authorisation application submitted to EMA on 29 December 2017; unlicensed in EU at time of meeting
Meeting context	Hospital departmental/MDT meeting; request said to have been made by two health professionals in December 2017
Key evidence issue	Different slide sets: complainant photos (9 slides) vs company deck (32 slides) with prominent “investigational/not licensed” wording
Panel decision	No breach (company could rely on Clause 1.2 unsolicited request exemption on balance of probabilities)
Clauses considered	2, 9.1, 3.1, 15.2, 15.9 (and Clause 1.2 referenced)
Complaint received	12 March 2018
Case completed	18 October 2018
Appeal	No appeal
Applicable Code year	2016

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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, non-contactable complainant (described as a consultant neurologist) alleged pre-licence promotion of Epidiolex (cannabidiol) at a hospital multi-disciplinary team meeting in February 2018.
At the time, a marketing authorisation application had been submitted to the EMA (29 December 2017) for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome.
The complainant provided photographs of nine slides and said they were later told the product was not licensed/available to prescribe in the UK/Europe.
GW Pharmaceuticals said the meeting was held in response to an unsolicited request from two health professionals (made verbally in December 2017) for an update on clinical data and properties of cannabidiol, and that the content was scientific/medical, not promotional.
A third-party organisation employed managers who represented GW Pharmaceuticals; the Panel noted GW was responsible for third parties acting on its behalf.
There was a dispute about which slide deck was used: the complainant’s photos lacked licensing warnings; GW’s 32-slide deck included prominent “investigational/not licensed” wording on many slides and a disclaimer slide stating it was not FDA/EMA approved.
The Panel noted concerns about the meeting (including lack of formal documentation) and observed the slides included proposed indications, usage and dosage, which could make HCPs view it as a pre-licence product.
However, GW provided evidence supporting an unsolicited request (emails, contemporaneous notes, attendee list, statements, and a signed transcript/record of a call with a requesting health professional).

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Outcome

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No breach of Clause 3.1 (promotion prior to marketing authorisation) on the particular facts, because GW could rely on the unsolicited request exemption.
Consequently, no breach of Clauses 15.2, 9.1 and 2.
No breach of Clause 15.9 (Panel did not consider the allegation raised a Clause 15.9 matter).
No appeal.

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AUTH/3024/3/18: Anonymous hospital consultant v GW Pharmaceuticals (Epidiolex) – no breach (unsolicited request exemption)

Key facts

What happened

Outcome

Clauses

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