AUTH/3654/5/22 - Health professional v Novartis

Allegations about an Entresto (sacubitril/valsartan) promotional video on alearned society’s website

  • Received
    23 May 2022
  • Case number
  • Applicable Code year
  • Completed
    25 May 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary


This case was in relation to a Novartis promotional symposium video hosted on a learned society’s website following its conference in September 2021.

The Panel ruled a breach of the following Clauses of the 2021 Code for failing to state that Entresto should not be initiated in patients with SBP [systolic blood pressure] < 100 mmHg or serum potassium level >5.4 mmol/l and for failing to include Entresto prescribing information within the video:

Breach of Clause 6.1

Misleading material that was not sufficiently complete to enable viewers to form their own opinion of the therapeutic value of the medicine

Breach of Clause 12.1

Failing to include prescribing information

Breach of Clause 5.1

Failing to maintain high standards

The Panel ruled no breach of the following Clauses of the 2021 Code as:
• The video had been certified.
• The complainant had made a very narrow allegation with regard to checking hepatic function as per the SPC, however, Novartis submitted that monitoring of liver function was not a specific requirement of Entresto.
• There was no allegation that information in the video was not capable of substantiation.
• The Panel considered that the matter in relation to the omission of prescribing information was covered by its ruling of breaches of Clauses 12.1 and 5.1 and an additional ruling of a breach of Clause 2 was not required.
• Whilst concerned about the editing of the video, overall, the Panel considered that health professionals would likely be left with the impression that there were important clinical considerations with the use of Entresto, including in relation to potassium and blood pressure, prompting them to refer to more detailed information such as the SPC prior to use of Entresto; on balance, the Panel did not consider that the video meant that Novartis had reduced confidence in, or brought discredit upon, the industry.

No Breach of Clause 6.1

Requirement that information must not be misleading 

No Breach of Clause 6.2

Requirement that information must be capable of substantiation 

No Breach of Clause 8.1

Requirement to certify promotional material 

No Breach of Clause 5.1


Requirement to maintain high standards 


No Breach of Clause 2

Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 

This summary is not intended to be read in isolation.
For full details, please see the full case report below.