AUTH/3329/3/20 - Complainant v Boehringer Ingelheim

Alleged promotion of Pradaxa to the public

  • Received
    14 April 2020
  • Case number
    AUTH/3329/3/20
  • Applicable Code year
    2019
  • Completed
    26 January 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 the on-line promotion of Pradaxa (dabigatran) by Boehringer Ingelheim. Pradaxa was an anti-thrombotic medicine indicated for use in the treatment or prevention of thrombotic events in adults including the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors.

The complainant provided a screenshot of what looked like the opening page of the pradaxa.co.uk website which presented the reader with two boxes one aimed at UK health professionals and the other aimed at patients prescribed Pradaxa/members of the public where each of the intended audiences could click on a link for more information about the medicine. The complainant alleged that encouraging both members of the public and patients on treatment to use one of the boxes to seek more information about Pradaxa, constituted promotion to the public.

The detailed response from Boehringer Ingelheim is given below.

The Panel noted that the Code prohibited the advertising of prescription only medicines to the public. It permitted information to be supplied directly or indirectly to the public but such information had to be factual and presented in a balanced way. The supplementary information allowed for the provision of non-promotional information about prescription only medicines to the public as reference information made available by companies on their websites or otherwise as a resource for members of the public. It was considered good practice for such reference material to include, as a minimum, the SPC, the package leaflet (PIL) and the public assessment report (PAR) (UK or European) where such a document existed. Regulatory documents and reference material on the Internet made available to the public must not be presented in such a way as to be promotional in nature.

The Panel noted that the website in question was primarily aimed at health professionals and although members of the public might find it via an Internet search, they were not proactively directed to it or encouraged to access it. The Panel noted that the landing page clearly separated the link intended for health professionals from the link intended for patients prescribed Pradaxa/members of the public and according to Boehringer Ingelheim directed each to the information tailored for them. The Panel noted Boehringer Ingelheim’s submission that the ‘Information intended for: Patients Prescribed Pradaxa/Members of the Public’ button redirected users through to non-promotional, factual reference information about Pradaxa that was suitable to be viewed by both patients prescribed Pradaxa and members of the public. It included a short product overview of the medicine and its possible side effects and provided links to the Pradaxa patient information leaflets (ie the leaflets contained in the packs), the SPCs and patient alert card and the EPAR via links.

The Panel considered that the complainant had not discharged his/her burden of proof that the information provided on the website, and intended for both patients prescribed Pradaxa and members of the public, constituted promotion of Pradaxa to the public or that high standards had not been maintained and no breaches of the Code including Clause 2 were ruled.