Daiichi Sankyo & AstraZeneca: UK employees’ LinkedIn ‘likes’ brought US trial post into UK Code scope (AUTH/3411/10/20, AUTH/3412/10/20)

📅 2020 | 🖉 Dr Anzal Qurbain
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Key facts

Case numbersAUTH/3411/10/20; AUTH/3412/10/20
PartiesComplainant v Daiichi Sankyo and AstraZeneca
IssuePromotion of a Phase 3 trial on LinkedIn; employee ‘likes’ treated as proactive dissemination in the UK
PlatformLinkedIn (post plus linked press release; post included short video)
Medicine/compoundEnhertu (fam-trastuzumab deruxtecan-nxki); compared vs ado-trastuzumab emtansine (T-DM1) in DESTINY-Breast05
ComplainantConcerned UK health professional
Complaint received2 November 2020
Case completedAUTH/3411/10/20: 4 June 2021; AUTH/3412/10/20: 14 December 2021
Applicable Code year2019
Clauses considered3.1, 9.1, 26.1
Breaches3.1; 9.1
No breach26.1 (Enhertu not classified as a prescription only medicine in the UK at the time; narrow technical point)
SanctionsUndertaking received; additional sanctions not stated
AppealNo appeal

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

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What happened

  • A UK health professional complained about a Daiichi-Sankyo Inc LinkedIn post announcing initiation of the DESTINY-Breast05 Phase 3 trial for HER2+ early breast cancer, linking to a press release about ENHERTU vs T-DM1.
  • The post appeared on the complainant’s LinkedIn feed and included an 8-second video (“BREAST CANCER UPDATE”) with Daiichi-Sankyo branding.
  • The complainant alleged the post had been ‘liked’ by at least one Daiichi-Sankyo UK employee and that it looked like promotion to the public and promotion before a licence.
  • Because the post referenced AstraZeneca as collaborator, the PMCPA took the complaint up with both Daiichi Sankyo and AstraZeneca.
  • Panel found that:
    • Two Daiichi-Sankyo UK employees had ‘liked’ the post (AUTH/3411/10/20).
    • One UK-based AstraZeneca employee had ‘liked’ the post (AUTH/3412/10/20).
  • The Panel considered that ‘liking’ on LinkedIn would, on the balance of probabilities, proactively disseminate the post (and its linked press release) to the employee’s UK connections, bringing it within scope of the UK Code.
  • Enhertu was not commercially available in the UK at the time; the linked press release included the US FDA-approved indication and referenced EMA accelerated assessment.
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Outcome

  • Daiichi Sankyo (AUTH/3411/10/20): Breach of Clauses 3.1 and 9.1; no breach of Clause 26.1 (on a narrow technical point).
  • AstraZeneca (AUTH/3412/10/20): Breach of Clauses 3.1 and 9.1; no breach of Clause 26.1 (on a narrow technical point).
  • Panel reasoning on Clause 26.1: Enhertu was not classified as a prescription only medicine in the UK at the time; Clause 26.1 applies to POMs only.
  • Panel reasoning on Clause 3.1: the ‘likes’ amounted to promotion of an unlicensed medicine (promotion prior to marketing authorisation).
  • Panel reasoning on Clause 9.1: despite clear internal policies, employees did not follow them; therefore high standards were not maintained.
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