AUTH/3282/11/19 - ViiV/Director v Gilead

Breach of undertaking

  • Received
    21 November 2019
  • Case number
  • Applicable Code year
  • Completed
    29 January 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the review

Case Summary

ViiV Healthcare UK Ltd alleged that Gilead Sciences Europe Ltd had breached its undertaking given in Case AUTH/3137/12/18 by continuing to use the claim that Biktarvy (bictegravir/emtrictabine/tenofovir) was ‘Better tolerated than DTG [dolutegravir] – containing regimens’. Biktarvy was used in the treatment of adults infected with human immunodeficiency virus-1 (HIV-1). ViiV promoted Juluca (dolutegravir/rilpivirne) for the treatment of HIV-1 infection in adults.

ViiV noted that the claim at issue was the subject of an unsuccessful appeal by Gilead and was ruled to be in breach by the Code of Practice Appeal Board on 9 October 2019. ViiV provided screenshots from 20 November which showed that the claim was still being used on a UK accessible website. Given that Gilead owned the website, ViiV stated that it would have expected a complete and immediate withdrawal of the offending claims following the appeal decision.

The complaint was also taken up in the name of the Director as the Authority was responsible for ensuring compliance with undertakings.

The response from Gilead is detailed below.

The Panel noted that a form of undertaking and assurance was an important document. Companies had to give an undertaking that the material in question and any similar material, if not already discontinued or no longer in use would cease forthwith and give an assurance that all possible steps would be taken to avoid similar breaches of the Code in future. It was very important for the reputation of the industry that companies complied with undertakings.

The Panel noted that in Case AUTH/3137/12/18, Gilead accepted that the claim in question was in breach of the Code; its undertaking was dated 18 November 2019.

Turning to the present case, Case AUTH/3282/11/19, ViiV noticed that the claim in question was still in use on 20 November on a Gilead-owned UK accessible website. There had thus been a failure to comply with the undertaking given in Case AUTH/3137/12/18 and a breach of the Code was ruled as acknowledged by Gilead. High standards had not been maintained and a further breach was ruled as acknowledged by Gilead.

The Panel considered that Gilead’s failure to comply with its undertaking brought discredit upon, and reduced confidence in, the pharmaceutical industry. A breach of Clause 2 was ruled.