Novartis vs Bayer

Bayer clearly saw what Novartis was up to, and got the Code Committee of the Medicines Advertising Code Foundation (Committee) to order Novartis to cease using certain claims regarding their product Beovu in their advertisements. A reminder to always make sure that claims in ads are substantiated sufficiently. 

The ad

The ad shows an impressionist painting, in which a specialist will immediately recognise a positive Optical Coherence Tomography-scan. Four claims are visible below the image: 

• 'We see a beautiful, dry retina'
• 'This is how beautiful an OCT-image, free of retinal fluid, can be*'
• 'That is our mission: more patients free of retinal fluid (1,2)'
• 'FLUID UNDER CONTROL
  DISEASE UNDER CONTROL'

The rules

Advertisements are not allowed to contradict the SmPC of a pharmaceutical. They should stimulate rational use of the pharmaceutical in terms of pharmacotherapy and the addressee of the advertisement should not be misled in any way.

When determining whether an advertisement is in line with the above, it is relevant whether the advertisement is accurate, current, truthful and whether all elements of the advertisement are correct and verifiable and provide a complete and precise representation of how the pharmaceutical works. To determine this, it is relevant whether the claims are sufficiently scientifically substantiated. 

The judgement 

The Committee states that with health claims 1 – 3, Novartis suggests that treatment with Beovu leads to a dry retina, which could be beneficial for patients with nLMD (neovascular age-related macular degeneration). The defence of Novartis, claiming that this would only be a goal to achieve, is set aside. As a next step, the Committee considers that these claims are not sufficiently substantiated. Footnote 2, referring to a study named ‘HAWK and HARRIER’, is not sufficient as this study merely makes clear that Beovu is not inferior to Eylea (Bayer’s product).  

With claim 4, the Committee in short considers that Novartis suggests that Beovu would decrease the presence of retinal fluid and thus the disease can be controlled. Not the SmPC nor the ‘HAWK and HARRIER’ study that forms the basis of the SmPC confirms this statement, according to the Committee.  

In a final attempt, Novartis proposes to publish the ad without any reference to the ‘HAWK and HARRIER’ study. To no avail: the Committee considers that the misleading character of the claims would still be present, even when the study is not referred to. 
Novartis is ordered to cease the use of the claims. The violation is not as serious that a rectification should take place, but Novartis is ordered to pay (limited) costs.

The take-away

While the Committee is not a regular court (it is part of a mechanism of self-regulation), its decision is binding for the parties involved and once again makes clear that substantiating claims in ads is not a simple task. Studies that are referred to must confirm the statements that are made one-on-one.