Leo Pharma: MSL activity deemed promotional, triggering ABPI exam requirement (AUTH/3244/9/19)

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Key facts

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Case	AUTH/3244/9/19
Parties	Employee v Leo
Company	Leo Pharma
Topic	Conduct of the Medical Scientific Liaison (MSL) Team
Complaint received	13 September 2019
Case completed	20 July 2020
Applicable Code year	2019
Appeal	No appeal
Breach clauses	9.1; 16.3
No breach clauses	2; 3.1; 3.2; 9.1; 16.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Product referenced	Kyntheum (in allegation)

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

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An anonymous, non-contactable complainant (stating they were a Leo Pharma employee) raised concerns about the dermatology Medical Scientific Liaison (MSL) team.
Allegations included: MSLs ran promotional meetings but did not have to pass the ABPI exam within 2 years; MSL and medical information emails provided unsolicited off-label/pre-licence information (referencing Kyntheum launch); an MSL receiving an award blurred the line between sales and medical; and MSLs lacked compliance training/direction.
Leo said the MSL role was strictly non-promotional, MSLs were not allowed to run promotional meetings, and they were trained on the Code (via an external online vendor). Leo described MSL activities including speaking at “educational meetings” (sometimes organised by Leo including sales), reactive meetings on request, and study/real-world evidence related visits.
The Panel considered that proactive presentations by Leo staff (including MSLs) at speaker meetings organised by the company (including sales) could be promotional, even if “predominantly educational”.

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Breach found: Clause 16.3 (appropriate examination) and Clause 9.1 (high standards).
No breach found: Clauses 16.1, 3.1, 3.2, 2, and (separately) no breach of Clause 9.1 in relation to the internal award allegation.
The Panel did not find evidence supporting allegations about unsolicited off-label/pre-licence information in emails, or that the award blurred sales/medical boundaries.

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