Advert - Otsuka Europe – Cases AUTH/3041/6/18 and AUTH/3123/11/18

• Date posted
  25 June 2020
• Sanction
  Advertisement,
• Case number/s
  AUTH/3041/6/18 and AUTH/3042/6/18 - Employee v Otsuka Europe and Otsuka UK

Otsuka Europe – Cases AUTH/3041/6/18 and AUTH/3123/11/18

For failing to implement timely changes to summaries of product characteristics (SPCs) and make consequential changes to its promotional material, Otsuka Europe was publicly reprimanded
by the Code of Practice Appeal Board, which considered that the company’s failures had the
potential to impact patient safety (see May 2019 Code of Practice Review). Otsuka Europe was also
required to be audited. At the consideration of the audit reports the Appeal Board noted that Otsuka Europe had previously not provided it with accurate information. Self-regulation relied, inter alia, on the
provision of accurate information. The Appeal Board subsequently publicly reprimanded Otsuka Europe
for a second time and required a re-audit of its procedures in relation to the Code.