AUTH/3647/5/22 - Voluntary admission by Leo

Uncertified promotional material

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

Case Summary

This was a voluntary admission by Leo in relation to the ‘At a glance’ and ‘Mode of action’ webpages of the Kyntheum (brodalumab) promotional website. The matter had come to Leo’s attention following its investigation in relation to Case AUTH/3503/4/21.

The Panel ruled a breach of the following Clause of the 2019 Code, in relation to each webpage, as material published on the ‘At a glance’ webpage differed to that which was certified, and material approved for the global website had in error been uploaded to the UK website for the ‘Mode of action’ webpage:

Breach of Clause 14.1

Failing to certify promotional material as required by the Code

The Panel ruled a breach of the following Clause of the 2019 Code as, in its view, the certification process underpinned self-regulation and the Panel was concerned that Leo did not have adequate control over its promotional materials:

Breach of Clause 9.1

Failing to maintain high standards

The Panel ruled no breach of the following Clause of the 2019 Code as allegations about the content of the webpages at issue were addressed in the previous case (Case AUTH/3503/4/21), and the Panel considered that the matter in relation to uncertified promotional material in this voluntary admission (Case AUTH/3647/5/22) was adequately covered by its rulings above:

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.