AUTH3205/6/19 - Voluntary Admission by Boehringer Ingelheim

Lack of certification and obligatory information

  • Received
    11 June 2019
  • Case number
  • Applicable Code year
  • Completed
    10 September 2019
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2020 Review

Case Summary

Boehringer Ingelheim admitted breaches of the Code in that e-learning material for the Respimat device, was made live on a third party agency’s website before it had been certified.  In addition, the agency involved which was contracted by Boehringer Ingelheim emailed health professionals on its database alerting them to the material.  Boehringer Ingelheim had no prior knowledge of, nor had it approved/certified, the promotional email.  The email sent by the agency did not contain prescribing information or other obligatory information for promotional materials.  The Respimat device was a type of inhaler used for several Boehringer Ingelheim respiratory medicines.

As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Boehringer Ingelheim.

The detailed response from Boehringer Ingelheim is given below.

The Panel noted that instead of one piece of material (‘How to use’ downloadable pdf), the agency uploaded the whole e-learning course to its live website.  The emails between the agency and Boehringer Ingelheim were confusing and not particularly clear in relation to what had and what had not been approved.  The emails showed that Boehringer Ingelheim was asked to check the website and confirm that it was ready to make the course live in a particular area for a three-month trial.  In the Panel’s view, given the content of the correspondence from Boehringer Ingelheim, it was not unreasonable for the agency to assume that it could make the whole e-learning course live. 

The Panel noted that Boehringer Ingelheim described the material for the website as educational and non-promotional in nature to assist pharmacists with supporting patients who might be on a product using a Respimat device.  Three Boehringer Ingelheim products were available in this device, Spiolto (tiotropium and olodaterol), Spiriva (tiotropium) and Striverdi (olodaterol).

The Panel noted that although some of the materials for the e-learning had been approved individually for different uses, such as in sales aids, the material made available on the website had been published prior to certification for such use by Boehringer Ingelheim.  The Panel therefore ruled a breach of the Code as acknowledged by the company. 

The Panel noted that the agency had also emailed those registered on its database.  The email referred to the training course ‘How to support patients with a Spiriva Respimat Device’.  The Panel noted that the agency did not appear to have contacted Boehringer Ingelheim about the email; the agency had let down Boehringer Ingelheim in that regard.  The email had not been certified and did not meet the requirements for the provision of prescribing information.  In addition, the email did not include the required statement regarding the reporting of adverse events and the non-proprietary name was not adjacent to the first appearance of the brand name.  Although the date of sending the email was included on the email it was not clear whether this was the date that the content was drawn up.  The Panel therefore ruled breaches of the Code as acknowledged by the company.