AUTH/3502/4/21 - Complainant v Daiichi Sankyo

Promotion of Olmesartan, Prasugrel and Edoxaban on Daiichi-Sankyo website and breach of undertaking

  • Received
    10 April 2021
  • Case number
    AUTH/3502/4/21
  • Applicable Code year
    2019
  • Completed
    06 December 2021
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous complainant, who could not be contacted using the contact details provided, alleged that Daiichi-Sankyo had promoted medicines to the public via its website in breach of its undertaking given in Case AUTH/3107/10/18.

The complainant submitted that following on from his/her recent complaints (Cases AUTH/3497/3/21 and AUTH/3499/4/21), he/she had been made aware of another major error on another website page.

The complainant noted that this particular page was accessible by anyone including health professionals, patients and members of the public. Providing product name, indications, descriptions, mechanisms of actions and superlatives in regard to three products was shocking and showed a lack of understanding of the Code. The complainant alleged that it was clear promotion to the public. The complainant stated that, in addition, it was also promotional to health professionals and therefore needed certification and mandatory promotional information. No prescribing information was provided and therefore it was in breach of multiple clauses of the Code. The complainant alleged that this was once again a breach of undertaking considering previous case rulings against Daiichi-Sankyo. The complainant further alleged that use of the word ‘excellent’ in describing olmesartan was inappropriate in breach of the Code. The complainant stated that the way Daiichi-Sankyo continued to operate, despite multiple compliance failings over a number of years, was a huge disrespect to the Code and the industry. Signatory knowledge was lacking and in view of the multiple compliance errors and continual poor practice, the PMCPA ought to consider temporary suspension from membership to protect patient safety.

The detailed response from Daiichi-Sankyo is given below.

The Panel noted Daiichi-Sankyo’s submission that the draft content on the webpage at issue was created by Daiichi-Sankyo Europe (DSE) Corporate Communications team; it was stored in draft format only in the website wireframe and was never intended for external publication on the Daiichi-Sankyo UK website.

The Panel noted Daiichi-Sankyo’s submission that as a result of a quality control error by Daiichi-Sankyo Europe, the status of the page was incorrectly set as live. The page was thus accessible through certain search terms on the Daiichi-Sankyo UK website, such as Daiichi-Sankyo product or brand names.

In the Panel’s view, the webpage at issue promoted edoxaban, prasugrel and olmesartan and would potentially be seen by a broad audience including members of the public. The Panel noted the statements on the webpage at issue and considered that they might encourage members of the public to ask their health professional to prescribe a specific prescription only medicine. The Panel therefore ruled breaches of the Code in relation to each medicine, as acknowledged by Daiichi-Sankyo.

The Panel noted its comments and rulings above. It appeared to the Panel that any user of the website could access the webpage in question if certain terms were searched for in the website’s search function and the intended audience for the webpage had not been identified. The website contained promotional material which was not restricted to health professionals and other relevant decision makers as set out in the relevant supplementary information and a breach of the Code was ruled.

The Panel did not consider that the webpage was aimed at patients prescribed a Daiichi-Sankyo medicine and therefore the requirement to include information about reporting side effects was not relevant and no breach was ruled.

The Panel ruled a breach as Daiichi-Sankyo had failed to maintain high standards. The Panel did not consider that the particular circumstances in this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such. No breach of Clause 2 was ruled.

The Panel noted Daiichi-Sankyo’s submission that the corporate website was not promotional material and was not aimed at health professionals or other relevant decision makers. The Panel noted it comments above that, in its view, the webpage at issue was promotional and therefore the requirements of the Code in relation to promotional material would apply in that regard. The Panel noted Daiichi-Sankyo’s submission that the webpage in question had not been approved for publication on the Daiichi-Sankyo UK website; it had not been reviewed by a signatory as required by the Code. The Panel therefore ruled a breach of the Code.

The Panel noted its comments above that in its view the webpage at issue was promotional and therefore prescribing information would be required for the health professional audience but had not been included. The Panel therefore ruled a breach of the Code in relation to Olmesartan, Prasugrel and Edoxaban.

The Panel noted its comments and rulings above and considered that Daiichi-Sankyo had failed to maintain high standards in this regard and a breach of Clause 9.1 was ruled. The Panel noted that Clause 2 was a sign of particular censure and reserved for such use. The Panel did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 and ruled no breach accordingly.

With regard to the claim ‘Olmesartan is an angiotensin receptor blocker (ARB) with excellent blood pressure lowering efficacy’, the Panel noted Daiichi-Sankyo’s submission that the use of the superlative, excellent, was inappropriate and a breach of the Code was ruled as acknowledged by Daiichi- Sankyo. The company had failed to maintain high standards and a breach of the Code was ruled.

The Panel noted that in Case AUTH/3107/10/18, Daiichi-Sankyo was ruled in breach of the Code as a webpage on the corporate website advertised prescription only medicines to the public and access to that webpage had not been restricted to health professionals and other relevant decision makers and its undertaking, accepting the Panel’s decision, was dated 22 February 2019. Turning to the present case, Case AUTH/3502/4/21, the Panel ruled breaches of the Code because the webpage in question on the corporate website promoted prescription only medicines to the public and access to the webpage had not been restricted to health professionals. There had thus been a failure to comply with the undertaking given in Case AUTH/3107/10/18 and a breach of the Code was ruled. The Panel considered that high standards had not been maintained and a breach of the Code was ruled.

The Panel noted Daiichi-Sankyo’s submission that it took all the necessary steps to ensure that the material in question with regards to Case AUTH/3107/10/18 was discontinued, removed and no longer in use. The Panel further noted Daiichi-Sankyo’s submission that the corporate website page at issue was never intended to be externally facing and was visible only as a result of an undetected backend error when it was mistakenly enabled as a result of a quality control error by Daiichi-Sankyo Europe.

The Panel noted that inadequate action leading to a breach of undertaking was an example of an activity likely to be in breach of Clause 2. Whilst the Panel was concerned that Daiichi-Sankyo had only became aware of the availability of the webpage at issue on receipt of this complaint, noting its comments and rulings above, it did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and was reserved for such use. On balance, no breach of the Code was ruled.