AUTH/3384/9/20 - Complainant v Bayer

Promotion of Ventavis

  • Received
    09 September 2020
  • Case number
  • Applicable Code year
  • Completed
    29 March 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complainant, who described him/herself as a concerned UK health professional, complained about a ‘Dear Pharmacist’ letter (ref UK.PH.GM.VEN.2012.004) about the distribution and supply of Ventavis (iloprost trometamol) on Bayer Plc’s website.

Ventavis was a nebuliser solution indicated for the treatment of adults with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.

The complainant alleged that materials on Bayer’s website were visible to all and appeared to be extremely out-of-date. The complainant provided a link to the ‘Dear Pharmacist’ letter at issue which appeared to show that it had been available via the media section of Bayer’s website and appeared to have been placed in 2012 and had not been updated since. It appeared that the material had note been certified every two years, nor had the prescribing information been updated as required.

The detailed response from Bayer is given below.

The Panel noted Bayer’s submission that the letter identified by the complainant was intended for pharmacists to inform them of changes to the supply arrangements for Ventavis that were to take effect in May 2012. The letter was certified for distribution in May 2012 and was first used on 14 May 2012.

The Panel noted from Bayer that the letter had never been available on the corporate website although it had, for reasons unknown to the company, been located in the ‘resource area’ of the website. The resource area was not intended for direct access by anyone external to the company and appeared to essentially be a storage area. The Panel noted Bayer’s submission that it had previously considered that information kept in the resource area but not linked to a webpage could not be accessed by anyone outside the company. Bayer had not found any evidence that access to the resource area for the purpose of accessing the letter was ever granted to anyone outside the company.

The Panel noted Bayer’s submission that the letter could not be found by navigating any of the content available on the website when the complaint was received nor had it found any evidence that the letter was ever accessible by navigation from the website in 2012, or subsequently. Following further enquiry, Bayer understood that the letter could be found and accessed by an online search using specific search criteria, eg by searching on Google using the word ‘Ventavis’ and the name of the employee who signed the letter. Bayer understood that was possible because search engines such as Google could index all websites globally by using web crawlers that ‘spider’ the entire website including content not intended for public viewing, eg from the resource area where the letter was located. Once created, the index was stored in the search engine’s online search library which rendered the information searchable even though the content could not be accessed directly by searching the website itself.

The Panel noted that the complainant had not submitted his/her search strategy. The search strategy provided by Bayer relied on the person searching the internet to know not only the name of the medicine but also the name of the employee who signed the letter. The Panel considered that, on the evidence before it, the balance of probabilities was that the letter was not visible to all on the Bayer website as alleged. It appeared that due to indexing by Google, the complainant had indirectly accessed an area of the Bayer website which was intended for direct access only by company personnel and not health professionals or members of the public.

Although the Panel was concerned that material which did not appear to meet the requirements of the Code could be accessed via a Google search, it seemed reasonable in this case to consider the letter as material on an internal company page rather than that which was intended for UK health professionals. The Panel decided that in the particular circumstances of this case, the now out-of-date prescribing information on a stored document which was not ‘live’ on the company website did not amount to a breach of the Code as alleged and no breach was ruled.

Similarly, the Panel considered that the circumstances of this case did not amount to the promotion of a prescription-only medicine to the public and no breach of the Code was ruled.

The Panel noted that the letter was certified in May 2012 and had not been recertified since. In that regard, however, given that the letter was not still in use, it did not need to be recertified and so the Panel ruled no breach of the Code.

The Panel was concerned that, due to web crawlers over which Bayer had no control, the letter could be found via a Google search but, nonetheless, given its comments and rulings above, it considered that in the specific circumstances of this case, the company had not failed to maintain high standards. No breach of the Code was ruled.