AUTH/3885/3/24: Ever Pharma UK v Britannia Pharmaceuticals – off-licence promotion risk via nurse service package deal and sponsored symposium

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Key facts

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Case number	AUTH/3885/3/24
Parties	EVER Pharma UK Ltd v Britannia Pharmaceuticals Ltd
Product	APO-go (apomorphine hydrochloride)
Main issue	Alleged off-licence promotion via nurse service/package deal and sponsored symposium (home initiation inconsistent with SmPC)
Applicable Code year	2021
Complaint received	13 March 2024
Case completed	4 June 2025
Appeal	No appeal
Breach findings	Clause 5.1 (x2); Clause 11.2 (x2)
No breach	Clause 2
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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EVER Pharma complained that Britannia promoted APO-go (apomorphine hydrochloride) outside its marketing authorisation via a company-funded nurse service and at a sponsored meeting.
The SmPC (section 4.2) stated: “Apomorphine should be initiated in the controlled environment of a specialist clinic. The patient should be supervised by a physician experienced in the treatment of Parkinson’s disease (e.g. neurologist).”
EVER Pharma alleged Britannia nurses supported initiation/response tests in patients’ homes (apomorphine-naïve patients included), which MHRA confirmed would be off-label practice.
Britannia said its nurses operated under NHS Trust clinical governance via individual honorary contracts; home initiation occurred only on unsolicited written request from the prescribing HCP and was not routine (17 of 169 hospitals had requested it). Britannia said it did not record totals.
The Panel reviewed a template package deal agreement (March 2024) which stated the NHS clinical team would direct whether service was provided in clinic or at home, and referenced initiation at home if directed by the prescribing HCP.
EVER Pharma also raised a Britannia-sponsored symposium (Parkinson’s Disease Nurse Specialist Association meeting, 2022) where an external speaker included data from the APOKADO study on home initiation; Britannia accepted it could give the impression of promoting home initiation.

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Breach of Clause 11.2 (x2) – Promoting a medicine for an unlicensed indication (nurse service/package deal; sponsored symposium content).
Breach of Clause 5.1 (x2) – Failing to maintain high standards (linked to the above two matters).
No breach of Clause 2 – Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry.
Applicable Code year: 2021.
Appeal hearing: No appeal.

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