GW Pharmaceuticals website: Sativex claims without prescribing information and pre-licence promotion of Epidiolex (AUTH/3184/4/19)

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Key facts

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Case number	AUTH/3184/4/19
Parties	Complainant/Director v GW Pharmaceuticals
Material	Company website (gwpharm.co.uk); health professional section; patients/caregivers section; pipeline section
Medicines referenced	Sativex; Epidiolex (cannabidiol)
Main issues	Missing prescribing information for promotional Sativex content; pre-licence promotion of Epidiolex via pipeline content; alleged breach of undertaking
Applicable Code year	2016
Complaint received	24 April 2019
Case completed	18 November 2019
Appeal	No appeal
Breach clauses	3.1, 4.1, 4.6
No breach clauses	2, 3.2, 16.1, 26.1, 26.2, 28.1, 29
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A “concerned UK health professional” complained about GW Pharmaceuticals’ UK corporate website (gwpharm.co.uk).
GW was the marketing authorisation holder (MAH) of Sativex; in the UK, Sativex was promoted by Bayer (per GW).
GW had submitted a marketing authorisation application (MAA) to the EMA for Epidiolex (cannabidiol) for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome; other cannabinoid products were in development.
The complainant alleged the patients/caregivers section was not sufficiently delineated from the general public and there was no separate general public section.
The complainant alleged that the health professional section made claims for Sativex but did not include prescribing information.
The complainant alleged the “pipeline” section was “blatant pre-licence promotion” (including statements such as “highly promising data” and detailed information about Epidiolex and regulatory status).
Because an alleged breach of undertaking was raised, the Director took that aspect up (PMCPA responsibility for undertakings).

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Breach found: Clause 3.1 (promotion of an unlicensed medicine), Clause 4.1 (prescribing information not provided in promotional material), Clause 4.6 (internet promotional material lacked clear, prominent statement as to where prescribing information can be found).
No breach found: Clauses 2, 3.2, 16.1, 26.1, 26.2, 28.1, 29.
The Panel did not consider the ruling in this case to be a breach of the undertaking given in Case AUTH/3014/1/18.

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