AUTH/3153/1/19 - Anonymous v Otsuka Europe

Out-of-date promotional materials 

  • Received
    30 January 2019
  • Case number
  • Applicable Code year
  • Completed
    05 July 2019
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    May 2020

Case Summary


An anonymous, non-contactable individual who described themselves as a recent employee at Otsuka complained about material used at two overseas meetings.  The complainant submitted that he/she had reported the matters at issue but as nothing had happened, decided to complain to the Authority.

The first matter concerned an alleged out-of-date advertisement that was used in association with a congress in France held in March 2018 (European Psychiatric Association (EPA)) which the complainant alleged was non-compliant.

Secondly, the complainant alleged that materials used at the European College of Neuropsychopharmacology (ECNP) Congress held in Spain in October 2018 were unapproved. 

The detailed response from Otsuka Europe is given below.

The Panel noted Otsuka Europe’s submission that it had made funding available for Otsuka France to support the EPA Congress and as part of its sponsorship agreement it could place an advertisement in the final congress programme.  The advertisement used was retrieved from the CNS Resource Centre, for which it appeared Otsuka Europe was responsible.

The Panel ruled a breach, as acknowledged by Otsuka Europe, as the withdrawn advertisement placed in the EPA Congress programme had not been certified for such use.

The Panel considered that Otsuka Europe had failed to maintain high standards in relation to governance of withdrawn materials and a breach was ruled as acknowledged by Otsuka Europe. 

Whilst the Panel was very concerned that withdrawn material was available in the CNS Resource Centre and that it appeared, from Otsuka Europe’s submission, that there was only an informal agreement with the affiliates that if they used any material from the resource centre they must first obtain local approval for the item, it did not consider that the circumstances were such as to warrant a breach of Clause 2 which was a sign of particular censure.  On balance, no breach of Clause 2 was ruled.

The Panel noted Otsuka Europe’s submission that it had both promotional and non-promotional materials and activities at the ECNP Congress.

The Panel noted Otsuka Europe’s submission that of the 64 job bags relating to pieces of material used at or in relation to the congress, 62 had one or more errors including not being certified, being certified incorrectly, being certified after first use and being used before the final hard copy was certified.  According to interview notes materials included slides, invitations, agenda, abstract book and banner stand.  The Panel therefore ruled a breach of the Code as acknowledged by Otsuka Europe.

The Panel noted Otsuka Europe’s submission that its formal approval process in place at the time was not followed in relation to the certification and/ or checking of material used at the congress.  The Panel considered that Otsuka Europe had failed to maintain high standards and a breach was ruled.

The Panel noted the importance of certification and its role in underpinning the self-regulatory compliance system.  The Panel noted the scale of errors.  In addition, the Panel noted that these included a number of materials that had been used prior to final certification.  In the Panel’s view, the cumulative effect of the errors was that Otsuka Europe had reduced confidence in the pharmaceutical industry.  A breach of Clause 2 was ruled.

The Panel did not consider that the complainant had provided evidence that compliance had attempted to cover up the issues or were not doing anything about them as alleged and therefore ruled no breach of the Code in this regard.