Novartis heart failure therapy review service: complaint about third-party email implying ‘client product/therapy priorities’ (No breach)

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Key facts

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Case	AUTH/3193/4/19
Parties	Anonymous v Novartis Pharmaceuticals Ltd
Topic	Sponsored therapy review service (heart failure) delivered by a named third-party service provider
Medicine mentioned	Entresto (sacubitril/valsartan)
Key document at issue	Internal third-party email dated 14 August 2018 referencing “integrate client product/therapy priorities” and noting training pharmacists in heart failure for Novartis joint ventures
Applicable Code year	2016
Clauses considered	2, 9.1, 12.1, 19.2
Panel decision	No breach of Clauses 19.2, 12.1, 9.1; consequently no breach of Clause 2
Appeal	Appeal by complainants (on Clause 9.1) unsuccessful; no breach upheld
Complaint received	30 April 2019
Case completed	14 October 2020
Sanctions	None stated

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

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What happened

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An anonymous contactable group (GPs, NHS leaders, pharmacists, NHS patients and current staff from a named third-party service provider) complained about therapy review services delivered by that third party for multiple pharma companies, including Novartis.
The Novartis-supported service related to heart failure; Novartis marketed Entresto (sacubitril/valsartan) for symptomatic chronic heart failure with reduced ejection fraction.
The complaint relied on an internal third-party email (14 August 2018) sent to the third party’s clinical team, describing business adjustments and the need to “transition and integrate client product/therapy priorities into our internal resource and schedules”.
The email included a Novartis-specific line: “We have now trained our first pharmacists in Heart Failure as we launch the first joint venture (JVs) in the [named region]…”.
Complainants alleged the email evidenced commercial bias/return on investment expectations and that an ‘independent’ provider should not be integrating “client product/therapy priorities”. They alleged Clause 2.
The Authority asked Novartis to consider Clauses 2, 9.1, 12.1 and 19.2 (Code year 2016). Relevant extracts of the email (not the full email) were initially provided to Novartis.
Novartis denied the email showed product-linked bias for its service, stating the joint working aimed to improve heart failure detection and guideline-based care; it provided documentation (framework/work order, project initiation documents, protocols) and said materials did not link the service to a specific medicine.
The Panel reviewed the email in full for context and considered general risks with therapy review services and third parties, including perception and the possibility that recipients might interpret “product/therapy priorities” as increased prescribing.

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Outcome

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No breach of the Code was ruled in relation to Novartis.
No breach of Clauses 19.2 and 12.1 (2016 Code).
No breach of Clause 9.1 (high standards).
Consequently, no breach of Clause 2.
The complainants appealed the no-breach finding for Clause 9.1; the Appeal Board upheld the Panel’s decision and the appeal was unsuccessful.

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Key facts

What happened

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