AUTH/2921/12/16 - Voluntary Admission by Grunenthal

Promotion to the public

  • Received
    20 December 2016
  • Case number
    AUTH/2921/12/16
  • Applicable Code year
    2016
  • Completed
    29 January 2017
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    February 2017 Review

Case Summary

Grunenthal voluntarily admitted breaches of the Code in that a video, certified for internal use only, relating to Palexia SR (tapentadol prolonged release), had been uploaded to YouTube without its knowledge. The company considered that the video constituted promotion of Palexia to the public or would encourage a member of the public to ask their health professional to prescribe Palexia. On being notified of the posting on YouTube, the company ensured that the video was taken down immediately. 

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Grunenthal. 

Grunenthal stated that the video in question was originally used in January 2015 to reinforce key aspects relating to the Palexia SR 2015 brand plan to promotional field-based employees. The video was developed by Grunenthal's advertising agency using a third party production company. 

With Grunenthal's consent, the advertising agency submitted a shortened version of the video (minus references to sales targets and promotional material) for a pharmaceutical marketing award in January 2016. On successfully winning an award, and without the knowledge of Grunenthal or the advertising agency, the director of the video provided a copy of the shortened version to the actor who subsequently uploaded this to YouTube. 

Grunenthal fully accepted that it was wholly inappropriate for the video to appear on a publicly accessible Internet site but that it was ultimately responsible for the activities undertaken by third party service providers working on its behalf even when these occurred without its knowledge or instruction and constituted activities that the company would never sanction. Grunenthal therefore also accepted that on this occasion high standards had not been met. In view of the fact that information relating to a prescription only medicine, which was intended for internal company use only, had appeared on a publicly accessible Internet site, Grunenthal understood the seriousness of the situation and why the Panel might also wish to consider the requirements of Clause 2. 

The detailed response from Grunenthal is given below. 

The Panel understood that creative agencies and individuals would want to be able to show examples of their work. Whilst the video had not been uploaded by Grunenthal or its agency, it had been sent and uploaded by contractors of the agency. It was an established principle under the Code that pharmaceutical companies were responsible for work undertaken by third parties on their behalf. Pharmaceutical companies had to ensure that prescription only medicines were not advertised to the public. The Panel considered that Grunenthal had been let down by the third party working on its behalf. 

The Panel noted that the shortened video was presented as a broadcast from 'Arthur Tapentadol' from the 'Ministry of Chronic Pain Control' who described Palexia as 'a jolly good medicine' and 'a darned good product'. It was also stated that Tapentadol was 'just the ticket' and that persuading a doctor to prescribe it would be a 'piece of cake'.

The Panel noted that YouTube was an open access website and was not limited to professional use. The Panel considered that there was a difference between putting examples of pharmaceutical promotional material on an advertising agency's website, in a section clearly labelled in that regard and putting the same on YouTube. The Panel considered that placing a video on YouTube which referred to Palexia as, inter alia, 'a jolly good medicine', promoted a prescription only medicine to the public. The Panel considered that statements had thus been made in a public forum which would encourage members of the public to ask their health professional to prescribe Palexia. Breaches of the Code were ruled including that high standards had not been maintained. The Panel did not consider, however, that there had been a breach of Clause 2. Such a ruling was the sign of particular censure and reserved for such.​