Advert - Otsuka Europe and Otsuka UK

• Date posted
  08 August 2019
• Sanction
  Advertisement,
• Case number/s
  AUTH/3041/6/18 and AUTH/3042/6/18 - Employee v Otsuka Europe and Otsuka UK

  AUTH/3123/11/18 - Otsuka employee v Otsuka Europe

Otsuka Europe Cases AUTH/3041/6/18 and AUTH/3123/11/18, Otsuka UK Case AUTH/3042/6/18

For failing to communicate changes to the summaries of product characteristics (SPCs) from 2017 for Jinarc (tolvaptan), Samsca (tolvaptan) and Abilify (aripiprazole), update prescribing information and relevant materials and withdraw materials in a timely manner (Otsuka UK); and for failing to communicate SPC changes or provide up-to-date prescribing information (Otsuka Europe) each company was ruled in breach of the following clauses:

Clause 2       - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 4.1    - Failing to include up-to-date prescribing information

Clause 9.1    - Failing to maintain high standards

The Code of Practice Panel also had broader concerns about the governance within the two companies. In the subsequent Case AUTH/3041/6/18 Otsuka Europe was not transparent in its response as it had not disclosed relevant internal reports.

Following reports from the Panel the Appeal Board was very concerned that an overall failure of governance processes at Otsuka Europe and Otsuka UK to implement and update SPC changes and update materials in a timely manner had potential patient safety implications. Otsuka Europe and Otsuka UK were publicly reprimanded and were required to be audited.