AUTH/3370/8/20 - Complainant v Ferring

Concerns regarding certification of material on a website

  • Received
    11 August 2020
  • Case number
  • Applicable Code year
  • Completed
    29 January 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant, who described him/herself as a concerned UK health professional, complained about the recertification of promotional material available online. The material in question, a supplement entitled ‘Trends Urology and Men’s Health’, commissioned and sponsored by Ferring Pharmaceuticals Ltd included prescribing information for Nocdurna (desmopressin), indicated for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. The front cover of the supplement stated that it would be available on the Trends in Men’s Health website until December 2017. The complainant doubted that the item had been certified in the last two years since it was not supposed to be being used.

The detailed response from Ferring is given below.

The Panel noted Ferring’s submission that it had been unaware of the supplement at issue as it was owned by its European Commercial Organisation (‘ECO’, originally based in Switzerland but now disbanded). The supplement included the UK prescribing information which included the NHS price and the UK company’s address.

The Panel noted that the supplement was available online in a publication which had a European reach which would include the UK; the inclusion of the UK prescribing information meant that the supplement fell within the scope of the UK Code. Although the supplement had been placed by Ferring’s European affiliate, it was an established principle, acknowledged by Ferring, that UK companies were responsible for the acts/omissions of overseas parents and affiliates that came within the scope of the Code.

The Panel noted that an agreement, signed by the Ferring ECO, provided that the supplement would be withdrawn from the website six months after the initial posting which Ferring assumed would have been December 2017 as stated on the supplement. Whilst the agreement implied that all copies of the PDF should have been deleted at the same time, this had not been done by the publisher due to an error in its process which had been highlighted by this complaint.

The Panel noted that it was an established principle under the Code that pharmaceutical companies were responsible for third-parties even if that third-party failed to follow instructions from the pharmaceutical company.

The Panel noted Ferring’s submission that although the supplement was no longer accessible from a link on the Trends homepage, it had been removed automatically when the hosting period expired, it was still available on the microsite builder when the complaint was made. In addition, readers would still be able to access the PDF if they had saved the link to it in the builder and it could potentially also be found using search terms such as ‘nocturia’, ‘management of nocturia’ or ‘nocturia Ferring’. The Panel noted that the supplement was therefore available for over two and a half years beyond when it should have been.

The Panel noted that whilst Ferring had been asked to consider a clause related to the certification of material before use, no ruling was made in that regard as the complaint was about the recertification of the material; the complainant noting that the supplement was in use beyond when it should have been. The Code required that material which was still in use was recertified at intervals of no more than two years to ensure that it continued to conform with relevant regulations.

It appeared to the Panel from Ferring’s submission and the evidence provided that the supplement had not been certified when it was first published in June 2017 or subsequently, noting it was still available in August 2020 upon receipt of this complaint. A breach of the Code was ruled.

The Panel noted that that in addition to having been badly let down by its affiliate which did not include the UK in the approval process as required by the corporate standard operating procedures, Ferring had also been let down by the third-party agency whose procedures failed to delete the supplement PDF from the microsite builder in December 2017. The Panel noted its comments and rulings above and considered that high standards had not been maintained. A breach of the Code was ruled.