AUTH/3478/2/21 - Complainant v Boehringer Ingelheim

Alleged promotion of unlicensed medicines on LinkedIn

  • Received
    22 February 2021
  • Case number
    AUTH/3478/2/21
  • Applicable Code year
    2019
  • Completed
    07 September 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

An anonymous complainant, who described him/herself as a health professional, alleged that the use of LinkedIn by senior managers and other employees of Boehringer Ingelheim Limited was unethical as it promoted unlicensed medicines to, among others, health professionals, non-health professionals and members of the public. The complainant provided a link to a LinkedIn post which stated, ‘[Named person] likes this news story which mentions Boehringer Ingelheim “New SARS-CoV-2 neutralizing antibody enters clinical phase”’. There appeared to be a link to an article on a named website.

The complainant stated that the shared article named the new antibody as BI 767551 which was being examined and developed as a SARS-CoV-2 neutralising antibody administered through inhalation. The initial promotion (post), which detailed the company, the medicine and the proposed indication had been shared and ‘liked’ a number of times, further generating multiple views of the same post to all the recipient's connections, who each could then generate even more ‘views’ of the same article, with little or no control of the number of, or of whom the recipients might be. The complainant alleged that this activity promoted unlicensed medicines, failed to meet high standards and brought the industry into disrepute.

The detailed response from Boehringer Ingelheim is given below.

The Panel noted that the original article had, without the knowledge or consent of Boehringer Ingelheim, been ‘liked’ by two of its employees. The Panel considered that the UK employees’ engagement with the post, on the balance of probabilities, had proactively disseminated the material to their connections and had thus brought the LinkedIn post and associated article within the scope of the UK Code.

The Panel noted that the article, published in December 2020, was from the German Centre for Infection Research and reported the initiation of two Phase 1/2a clinical trials of a SARS-CoV-2 neutralising antibody which were being conducted in collaboration with Boehringer Ingelheim. The Panel noted that a German university was the legal sponsor of the two trials, not Boehringer Ingelheim, and that the trials would not be conducted in the UK.

The Panel considered that it was clear that the compound in question was in the early stages of development and that if the planned studies showed that it was well tolerated, further studies would be conducted. The compound was investigational so was not a prescription only medicine. The Panel thus did not consider that a prescription only medicine had been advertised to the public; no breaches of the Code were ruled.

The Panel considered that a compound, still only referred to by a number (BI 767551), which was just entering first-in-human (phase 1/2a) clinical trials, with no published clinical outcomes and available only in a clinical trial setting was a long way off being available as a medicine; it was clear that further work was needed. The Panel noted the early stage of development of the molecule and in that regard did not consider that a medicine had been promoted prior to the grant of a marketing authorisation. No breach of the Code was ruled.

The Panel noted that the Boehringer Ingelheim social media standard operating procedure clearly stated that employees must ‘Never discuss topics related to prescription pharmaceutical brands, Boehringer Ingelheim product-related information (in market or development), or any information related to competitor products, on personal Social Media accounts’. An associated e-learning programme had to be completed annually by UK employees. Whilst the Panel considered that it was unfortunate that two employees had acted in breach of company policy and training, it noted its rulings of no breaches of the Code and consequently ruled no further breaches of the Code including Clause 2.