AUTH/3238/8/19 - Anonymous v Vifor

Corporate website

  • Received
    12 August 2019
  • Case number
    AUTH/3238/8/19
  • Applicable Code year
    2019
  • Completed
    26 March 2020
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the review

Case Summary

An anonymous, non-contactable individual, who described him/herself as a ‘concerned UK health professional’, drew attention to the webpages for IV irons on Vifor Pharma UK Limited’s corporate website and complained that the inverted equilateral triangle symbols were variously blue, grey or white and not black.

The complainant was unclear as to whether the website was intended for the public or for health professionals as it included links to download leaflets for either patients or clinicians about IV irons.

The detailed response from Vifor is given below.

The Panel noted that the website at issue was Vifor’s corporate website which appeared to provide general information about the company. In the Panel’s view, although not clearly stated by Vifor, the website had to be non-promotional given that the company expected it to be accessed by the general public/patients and in that regard the Panel noted from material provided by the complainant that none of the webpages which dealt with products had URLs which referred to health professionals.

The Panel noted that the complainant had referred to links to information leaflets for either patients or health professionals about IV irons but had not provided copies of those leaflets; copies were provided by Vifor. The Panel noted Vifor’s submission that four of the five UK documents which were downloadable from the Ferinject (ferric carboxymaltose) webpage of the products section of the website were non-promotional items relating to formal risk management materials requested by the European Medicines Agency (EMA) and the Medicines and Healthcare product Regulatory Authority (MHRA). The two letters to health professionals had been jointly issued by Pharmacosmos, Vifor and Fresenius Medical Care and alerted readers to the risk of serious hypersensitivity reactions with IV iron products. The two leaflets, one for health professionals and one for patients, discussed the same matter. The fifth downloadable document, however, was published by the Scottish Medicines Consortium (SMC) in 2011 and detailed its assessment of Ferinject, stating that the product was accepted for restricted use in NHS Scotland. The document presented evidence on, inter alia, comparative efficacy, clinical effectiveness, cost of relevant comparators and budget impact. In the Panel’s view the SMC document, although non-promotional per se, had been used for a promotional purpose. The document, specifically about Ferinject, had been placed by Vifor on its corporate website and it clearly contained claims for the product. The Panel thus considered that, overall, the website was promotional.

The Panel noted Vifor’s submission that it had immediately deactivated the website at issue when it was informed of the complaint; the company had also removed all brand information from the site.

In the Panel’s view, the inverted black triangle was a well-known and established symbol for health professionals. Its appropriate use was an important part of medicines regulation and contributed towards patient safety; failure to publish the triangle in the correct colour was, at the very least, inappropriate and might potentially cause confusion. As the product webpages on Vifor’s corporate website were, in the Panel’s view, promotional and the inverted triangles on those pages were not black, a breach of the Code was ruled as acknowledged by the company.

The Panel noted that the Code stated that promotional material about prescription only medicines directed at a UK audience which was provided on the Internet must comply with all the relevant requirements of the Code. The supplementary information stated that unless access to promotional material about prescription only medicines was limited to health professionals and other relevant decision makers, a pharmaceutical company website or a company sponsored website must provide information for the public as well as promotion to health professionals with the sections for each target audience clearly separated and the intended audience identified. This was to avoid the public needing to access material for health professionals unless they choose to. The MHRA Blue Guide stated that the public should not be encouraged to access material which was not intended for them.

The Panel noted that the corporate website provided promotional information for health professionals and information for the public but there was no separation of the material – it was all presented together. A breach of the Code was ruled as acknowledged by Vifor.