Public reprimand for Otsuka Europe and Otsuka UK

Otsuka Pharmaceuticals Europe Limited and Otsuka Pharmaceuticals UK Limited have each been publicly reprimanded by the Code of Practice Appeal Board for failing to notify and/or implement changes to the summaries of product characteristics (SPCs) from 2017 for Jinarc (tolvaptan), Samsca (tolvaptan) and Abilify (aripiprazole) and update relevant materials in a timely manner (Cases AUTH/3041/6/18 and AUTH/3042/6/18 respectively). These failings had the potential to adversely impact patient safety. Otsuka Europe was also publicly reprimanded for these failings in a subsequent but overlapping case (Case AUTH/3123/11/18).

In Cases AUTH/3041/6/18 and AUTH/3042/6/18, Otsuka Europe and Otsuka UK were each ruled in breach of the Code, including of Clause 2 for bringing discredit upon, and reducing confidence in, the pharmaceutical industry. It was crucial that health professionals and others could rely upon the industry for up-to-date and accurate information about their medicines The Code of Practice Panel also had broader concerns about governance within the two companies and it decided to report Otsuka Europe and Otsuka UK to the Code of Practice Appeal Board.

In the subsequent case, Case AUTH/3123/11/18, Otsuka Europe’s response to the PMCPA in relation to Case AUTH/3041/6/18 was not transparent as the company had not disclosed relevant internal audit reports. The Panel considered that the further information disclosed in Case AUTH/3123/11/18 now showed that the magnitude of the compliance issues at Otsuka Europe was greater than apparent in Case AUTH/3041/6/18. The Code of Practice Panel ruled breaches of the Code including of Clause 2. The Panel also decided to report Otsuka Europe to the Appeal Board.

The three reports were considered at the same Appeal Board meeting.

In Cases AUTH/3041/6/18 and AUTH/3042/6/18 and Case AUTH/3123/11/18 the Appeal Board was very concerned that an overall failure of governance in relation to Otsuka Europe and Otsuka UK’s processes in implementing SPC changes, updating prescribing information and updating and withdrawing promotional materials in a timely manner had potential patient safety implications. This was a serious matter. Also at issue in Cases AUTH/3041/6/18 and AUTH/3042/6/18 was the timely update and submission to the Medicines and Healthcare products Regulatory Authority (MHRA) of risk minimisation materials.

In Case AUTH/3123/11/18, the Appeal Board was also concerned that Otsuka Europe had neither referred to nor provided the relevant internal audits of global and European functions in its response to Case AUTH/3041/6/18.

In addition to the public reprimand, the Appeal Board also decided to require an audit of Otsuka Europe’s (Case AUTH/3041/6/18 and Case AUTH/3123/11/18) and Otsuka UK’s (Case AUTH/3042/6/18) procedures in relation to the Code.