Public reprimands and suspension for Astellas

False response and further failure to provide accurate information

Astellas Pharma Europe and Astellas UK have been publicly reprimanded twice by the Code of Practice Appeal Board. Once for breaches of the Code in relation to providing false information in response to a previous case and for reporting the outcome of the previous case in a dismissive manner. Secondly for providing inaccurate information to the Authority.

In Case AUTH/2780/7/15, the Code of Practice Panel ruled breaches of the Code with regard to the provision of false information in response to a previous case (Case
AUTH/2747/1/15) and for the dismissive manner in which a senior employee reported the outcome of that case to Astellas staff. The Panel reported Astellas UK and Astellas Europe to the Appeal Board. The Appeal Board required a corrective statement to be issued; both companies were also publicly reprimanded and required to undergo audits of their procedures in relation to the Code.

Following the audits the Appeal Board decided that both companies should be reaudited in September 2016. In addition Astellas Europe subsequently admitted it had provided inaccurate information. This was considered by the Code of Practice Panel which again reported both companies to the Appeal Board. The Appeal Board decided to require a third corrective statement, to publicly reprimand both companies for a second time and to report them to the ABPI Board.
The ABPI Board was extremely concerned at the multiple organisational and cultural failings. There was institutional failure. Very senior staff at Astellas Europe had lied and there was deception on a grand scale which was appalling and shocking. The totally unacceptable behaviour of senior staff was potentially harmful to the integrity of self-regulation.

The ABPI Board suspended Astellas UK from membership of the ABPI for 12 months commencing on 24 June. It also decided that it wanted sight of the reports of the September 2016 reaudits of the companies so that it could review the position, including the length of the suspension, before the end of 2016. The reaudits must show demonstrable improvements at both companies particularly in relation to corporate culture. Astellas Europe and Astellas UK will continue to be required to comply with the Code and accept the jurisdiction of the PMCPA during the period of suspension.