AUTH/2837/4/16: Anonymous employee v Leo Pharma – internal Enstilar launch materials and MSL reporting line (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2837/4/16
Complainant	Anonymous, non-contactable employee
Company	Leo Pharma
Product	Enstilar (calcipotriol/betamethasone) cutaneous foam/spray foam
Main issues	(1) Alleged promotion of an unlicensed medicine to the public via internal office displays/emails; (2) Alleged inappropriate MSL reporting line to a sales manager
Materials at issue	Two internal emails; photos of large cut-out Enstilar aerosol cans; a screen image
Clauses considered	Clause 2; Clause 9.1; Clause 26.1
Decision	No breach of Clauses 2, 9.1 and 26.1
Complaint received	11 April 2016
Case completed	3 June 2016
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 employee complained about Leo Pharma’s internal communications ahead of the planned launch of Enstilar (calcipotriol/betamethasone) cutaneous foam/spray foam.
The complainant supplied two internal emails and photos of large cut-out Enstilar aerosol cans placed around the office, plus a screen image.
Allegation 1: Enstilar had no marketing authorisation at the time and the materials could potentially be viewed by visitors, amounting to promotion of a prescription-only medicine to the public.
Allegation 2: The reporting line for medical scientific liaison officers (MSLs) was inappropriate because a head of sales (thrombosis) would take on an interim role as head of MSLs for dermatology activities.
Leo said the materials were for internal staff engagement/familiarisation, displayed in secure office areas (open-plan, staff kitchen, internal meeting room), and access was controlled; visitors were typically taken to meeting rooms away from staff areas.
Leo said internal emails repeatedly reminded staff the product was not yet licensed externally and should not be discussed with external stakeholders unless specifically briefed.
On the MSL structure, Leo said overall governance of the MSL function remained with the medical director; it provided SOPs/job descriptions and a draft work instruction to mitigate conflicts during the interim arrangement.
After the initial ruling, Leo clarified there was one MSL team covering both dermatology and thrombosis (not two separate teams), with dual reporting depending on activity; the Panel reconvened to consider this clarification.

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Outcome

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No breach was found in relation to the alleged promotion of an unlicensed medicine to the public.
No breach was found in relation to the MSL reporting line arrangement (including after the Panel reconvened following Leo’s clarification).
No breach of the Code was ruled, including no breach of Clause 2.

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AUTH/2837/4/16: Anonymous employee v Leo Pharma – internal Enstilar launch materials and MSL reporting line (No breach)

Key facts

What happened

Outcome

Clauses

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