AUTH/3170/3/19: Health professional v Novartis — Entresto speaker meeting presentation (no breach) | PMCPA Case

📊

Key facts

⌄

Case	AUTH/3170/3/19
Parties	Health professional v Novartis Pharmaceuticals UK Ltd
Product	Entresto (sacubitril and valsartan)
Setting	Promotional speaker meeting (with educational focus)
Allegation	Presentation not fair/balanced; positives only; no side effects/adverse reactions (Clause 7.2)
Company response (summary)	Meeting included efficacy and safety slides (PARADIGM-HF), SPC-based prescribing content, and prescribing information in agenda and slide decks; all attendees present throughout
Panel decision	No breach of Clause 7.2
Applicable Code year	2016
Complaint received	14 March 2019
Case completed	17 September 2019
Appeal	No appeal
Attendance	12 health professionals (per Novartis)

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

An anonymous, contactable health professional (a GP) complained about a consultant cardiologist’s presentation on Entresto (sacubitril/valsartan) at a Novartis-organised and sponsored speaker meeting.
The allegation was that the presentation was not fair or balanced and only presented positives, with no information on potential side effects/adverse reactions.
The meeting (2019) ran 6:15pm–9pm and had three presentations: (1) economic burden/audit (non-product), (2) diagnosis & management in primary care (included efficacy and safety data for Entresto vs enalapril from PARADIGM-HF plus SPC-based practical prescribing), and (3) NYHA class and clinical outcomes (risk stratification; included some promotional claims and a “take home message” suggesting switching NYHA class II patients if appropriate).
Novartis stated all 12 attendees were present for all presentations; prescribing information was included on the invitation/agenda and at the end of the second and third presentations, and was available in hard copy.

⚖️

⌄

No breach of the Code was found.
The Panel ruled no breach of Clause 7.2 (fair balance) because, on balance, the primary message of the complained-about presentation was NYHA classification and the complainant did not specify which side effects/adverse reactions were missing; the burden of proof lay with the complainant.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access