AUTH/3059/8/18 - Anonymous, non-contactable v Lundbeck

Company webpage and certification of promotional material

  • Received
    20 August 2018
  • Case number
    AUTH/3059/8/18
  • Applicable Code year
    2016
  • Completed
    19 December 2018
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2019 Review

Case Summary

An anonymous, non-contactable complainant, who appeared to be a Lundbeck employee, complained about the product section of the Lundbeck website and the certification of promotional materials under a co-promotion agreement with Otsuka.  Lundbeck and Otsuka co-promoted Abilify Maintena (aripiprazole prolonged-release suspension for injection) which was indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

The complainant alleged that the product section of the company webpage was available to all and constituted promotion to the public.  Both the brand and generic names were stated and the complainant queried whether the prescribing information should have been provided.  The complainant further queried what additional information had been provided to consumers to ‘encourage correct usage’.

The complainant further alleged that a member of the Lundbeck medical department was responsible for Lundbeck not certifying materials correctly for the product it co-promoted with Otsuka; he/she had not realised that two signatories were required to certify items under co-promotion agreements and most of Lundbeck’s promotional material since this individual was appointed had not been certified correctly and was in breach of the Code.

The detailed response from Lundbeck is given below.

The Panel noted Lundbeck’s submission that the aim of the webpage in question was to provide the public with correct information about its products, including the doses where relevant, and their licensed indication.  The Panel noted that the webpage in question included the medicines’ brand names, non-proprietary names, dosages, formulations and indications in a tabular format.  Beneath the table was a link to the electronic medicines compendium (eMC) website homepage.

The Panel considered that given the combination of the medicine’s name and indication and the fact that members of the public looking for information on a particular product would see such information for all Lundbeck’s products meant that the webpage advertised prescription only medicines to the public and on the balance of probabilities might encourage members of the public to ask their health professional to prescribe a specific prescription only medicine and breaches of the Code were ruled.

The Panel noted that the supplementary information to the Code stated, inter alia, that under copromotion arrangements the companies concerned could agree to have only one final signatory to certify on behalf of all the companies, however, this must be agreed beforehand and the MHRA and PMCPA must be informed in advance who the signatory would be. 

The Panel considered that the time period within the scope of the complaint was from February 2017 onwards and noted that during this time a number of promotional items were certified by only one company without prior notification to the MHRA and PMCPA as required by the Code.  Other promotional material, which was signed by a registered medical practitioner or a pharmacist registered in the UK from one company and a commercial person from the other, was also ruled in breach of the Code.  The commercial person was no longer recognised as a final signatory under the Code and the relevant material had therefore only been certified by one company without prior notification to the MHRA and PMCPA.  Consequently, the materials had not been certified in accordance with the Code and breaches were ruled.