AUTH/3403/10/20 - Complainant v Consilient

Promotion of InVita D3 via an app

  • Received
    21 October 2020
  • Case number
  • Applicable Code year
  • Completed
    12 April 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 member of the public, alleged that within its app, Vitamin D Vitality, Consilient Health Ltd promoted InVita D3. The complainant noted that the app, which he/she had found on the Google Play Store, referred to InVita, had branded materials for everyone to see, even if the app was not downloaded, as well as prescribing information in the preview images (screenshots were provided). The complainant did not think that pharmaceutical companies were able to promote to members of the public. The last time Consilient seemed to have reviewed its content was three years ago, which seemed like a long time.

Consilient marketed Invita D3 (colecalciferol) for vitamin D deficiency.

The detailed response from Consilient is given below.

The Panel noted Consilient’s submission that the Vitamin D Vitality app was not registered as a medical device; it was developed by Consilient to help health professionals who had already decided to prescribe InVita D3 to identify the most appropriate product and dose. According to Consilient, by answering questions such as age of the patient, whether prophylaxis or treatment was required, frequency of dose etc, the app would guide the user to the most appropriate medicine with information about dose and frequency.

The Panel noted from the complainant’s screenshots that the app was categorised under ‘Health and Fitness’ by the developers rather than ‘Medical’ which might imply that it was suitable for members of the public rather than for a more specialist medical audience. In the Panel’s view, Consilient was responsible for the categorisation of the app. The Panel further noted that whilst beneath the heading ‘About this app’ within the Google Play Store it stated: ‘To help HCPs who have decided to prescribe InVita D3 select the appropriate dose’, it appeared that content from the app was visible before the app was downloaded including a reference to InVita D3 and its use in vitamin D deficiency and part of the prescribing information.

The Panel noted that whilst the Code did not specifically refer to apps, it did refer to the requirements for promotional material which was provided on the Internet and the Panel considered that those principles were relevant to promotional material on the Google Play Store and which could be downloaded from the Google Play Store such as an app.

In the Panel’s view, despite the statement which could be seen before downloading the app from the Google Play Store, ie that the app in question was ‘To help HCPs who have decided to prescribe InVita D3 select the appropriate dose’, the information that could be seen before downloading the app meant that a prescription only medicine had been advertised to the public and a breach of the Code was ruled.

In relation to the allegation that the content was last reviewed three years ago, the Panel noted Consilient’s submission that the prescribing information provided in the app was current and that the 2019 update to the summary of product characteristics had had no impact on the prescribing information. On the evidence before it the Panel ruled no breach of the Code.

The Panel noted that the app was first certified on 12 September 2017 and re-certified on 17 September 2019. The Panel noted therefore that the delay in re-certification meant that the requirements of the Code had not been met and a breach was ruled.

The Panel noted its comments and rulings above and considered that Consilient had failed to maintain high standards and a breach of the Code was ruled.

The Panel did not consider that the inclusion of the statement that the app was ‘To help HCPs who have decided to prescribe InVita D3 select the appropriate dose’ negated the fact that information which promoted InVita D3 was available to the public without having to download the app. In the Panel’s view this demonstrated a lack of care and awareness of the Code on matters that reflected UK law and Consilient had thus brought discredit upon, and reduced confidence in, the industry. A breach of Clause 2 was ruled.