Novartis breached ABPI Code after edited Beovu HCP video omitted safety caution (AUTH/3464/1/21)

📅 2021 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/3464/1/21
CompanyNovartis Pharmaceuticals UK Limited
ProductBeovu (brolucizumab)
MaterialEdited HCP video on a promotional Beovu website (‘First experience in [country]: Patient cases and implementation’)
Channel / accessHCP website accessed via QR code in Eye News advertisement (HCP confirmation gate noted by Novartis)
Main issueEdited video retained positive experience/case outcomes but omitted the presenter’s caution and risk-management context regarding intraocular inflammation
Applicable Code year2019
Complaint received26 January 2021
Case completed05 August 2021
AppealNo appeal
Breach clauses7.2, 9.1
No breach clauses10.2
SanctionsUndertaking received; additional sanctions not stated

Download the full case report (PDF)


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

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What happened

  • A healthcare practitioner complained about a Novartis promotional Beovu (brolucizumab) website hosting an edited HCP video titled ‘First experience in [country]: Patient cases and implementation’.
  • The complainant had attended the original July 2020 Novartis webinar and said the presenter had been balanced, stressing caution due to reports of retinal vasculitis/occlusions.
  • A QR code in a Beovu advertisement (Eye News, Dec/Jan 2021) directed HCPs to the Novartis website where the edited video could be viewed.
  • The edited video retained positive patient case comments (including very positive effects at 2 weeks) but omitted the presenter’s caution and practical controls/checks (eg, 2-week post-injection checks for signs of inflammation/endophthalmitis, and avoiding certain eyes).
  • Novartis said the on-demand video was an excerpt (not the full webinar), was certified (Nov 2020), was not intended to be viewed standalone, and safety information was incorporated elsewhere on the website in line with the SPC.
  • The Panel considered that the omission removed balance and context, making the video misleading about the presenter’s “first experiences” and “implementation”.
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Outcome

  • Breach of Clause 7.2.
  • Breach of Clause 9.1.
  • No breach of Clause 10.2 (Panel said the video was not a quotation, so the clause was not relevant).
  • Case completed: 5 August 2021 (complaint received 26 January 2021).
  • Appeal: No appeal.
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