LEO Pharma: UK employees’ LinkedIn ‘likes’ brought global posts into scope, triggering certification, PI and pre-licence promotion breaches (AUTH/3428/11/20)

📅 2020 | 🖉 Dr Anzal Qurbain
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Key facts

FieldDetails
Case numberAUTH/3428/11/20
PartiesAnonymous, contactable complainant v LEO
ChannelLinkedIn (global corporate page; UK employees’ engagement)
Complaint received11 November 2020
Case completed12 January 2022
Applicable Code year2019
Core issuesEmployee ‘likes’ treated as proactive dissemination; uncertified disease awareness (Clause 14.3); uncertified promotion (Clause 14.1); missing prescribing info/date; misleading safety claim; promotion prior to marketing authorisation; promotion of POM to public (in one post).
Medicines/subjects referencedEnstilar (PSO-LONG trial); tralokinumab (Phase 3 data referenced in “#PRESS” posts); disease awareness (psoriasis/eczema); pipeline IL-17A PPI compound (no breach for pre-licence promotion in Post D).
Sanctions appliedUndertaking received; Additional sanctions: Advertisement

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

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What happened

  • An anonymous, contactable complainant challenged LEO Pharma’s use of LinkedIn, focusing on a global corporate page (“Leo Pharmaceuticals Ballerup DK”) that UK audiences were directed to from the UK corporate website.
  • The complainant alleged UK employees’ LinkedIn reactions (eg ‘likes’, ‘support’, ‘celebrate’) effectively shared/disseminated posts to their connections, potentially including the public.
  • Fourteen posts (A–N) were cited, including disease awareness posts (psoriasis/eczema), congress/symposium content, pipeline content, and “#PRESS” posts linking to media/press release pages.
  • The Panel/Appeal Board considered that UK employees’ engagement with posts, on the balance of probabilities, proactively disseminated the material to their connections and brought the posts (and associated videos/links) within the scope of the Code.
  • Key problem areas included: (a) disease awareness content not certified as required; (b) promotional content for a POM (Enstilar) disseminated without certification/prescribing information/date; (c) a misleading safety impression (“No cases of skin atrophy”); and (d) dissemination of Phase 3 press-release style content about tralokinumab prior to marketing authorisation.
  • The Panel criticised LEO’s social media governance as unclear/contradictory (eg 2013 policy said product posts were “strongly discouraged” while a 2018 UK/IE card encouraged staff to “like and engage with our social media posts”).
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Outcome

  • Breach findings upheld on appeal for: Post A (Clause 14.3), Post C (Clauses 14.1, 4.1, 4.8, 7.2, 7.9, 3.2), Post H (Clause 14.3), Post L (Clause 14.1), Post N (Clause 14.1), and overall Clause 2.
  • Clause 2 breach (particular censure) was upheld due to multiple breaches including promotion prior to marketing authorisation and inadequate/unclear employee guidance.
  • Some allegations were not upheld (eg no breach for certain posts regarding promotion to the public, black triangle, teaser advertising, or where burden of proof not met for promotional status/certification).
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