Astellas Pharma Europe Ltd and Astellas UK named in advertisements following breaches of the ABPI Code of Practice
In addition Astellas UK Limited and Astellas Europe have been required to issue corrective statements and have been publicly reprimanded. Both companies have been required to undergo audits and Astellas UK has been suspended from membership of the ABPI.
Press Release 23 August 2016
Both companies have brought discredit upon, and reduced confidence in, the pharmaceutical industry.
Astellas Pharma Europe – Case AUTH/2780/7/15
For providing false information in response to Case AUTH/2747/1/15 (which was ruled in breach of the Code and related to arrangements for a meeting) and reporting the outcome of Case AUTH/2747/1/15 to its staff in a dismissive manner, both companies have been required to undergo audits and Astellas UK has been suspended from membership of the ABPI and was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 9.1 - Failing to maintain high standards.
The Code of Practice Panel reported Astellas UK, which was responsible under the Code for its European parent, and Astellas Europe to the Code of Practice Appeal Board(2). The Appeal Board noted that the UK health professionals who attended the meeting had been provided with a corrective statement and a case report which was misleading (Case AUTH/2780/7/15). This was totally unacceptable.
The Appeal Board decided to require Astellas UK and Astellas Europe to issue a second corrective statement to all the UK attendees at the meeting (Case AUTH/2780/7/15); in addition both companies were publicly reprimanded and required to be audited.
Following these audits Astellas Europe subsequently admitted it had provided inaccurate information. This was considered by the Panel which again reported Astellas Europe and Astellas UK to the Appeal Board which noted an institutional failure with respect to compliance. The Appeal Board decided to require a third corrective statement, to publicly reprimand both companies and to report them to the ABPI Board. The ABPI Board suspended Astellas UK from membership of the ABPI for 12 months commencing 24 June 2016(3). The ABPI Board wanted sight of the September 2016 re-audits so that it could review the position, including the length of the suspension, before the end of 2016. The re-audits must show demonstrable improvements at both companies2.
Notes to Editors:
(1) The advertisements will appear in the Pharmaceutical Journal on 27 August, BMJ on 3 September and Nursing Standard on 7 September 2016.
(2) The Code of Practice Appeal Board consists of an independent, legally qualified, chairman and includes independent members, as well as senior executives from pharmaceutical companies. For the consideration of any matter independent members, including the Chair, must be in a majority. Further details are available in the PMCPA Constitution and Procedure.
(3) The original ABPI press release was issued on 24 June 2016, see updated release
The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the ABPI. The PMCPA is a division of the ABPI. The Code covers the promotion of medicines for prescribing to health professionals and the provision of information to the public about prescription only medicines. If you have any concerns about the activities of pharmaceutical companies in this regard, please contact the PMCPA at 7th Floor, 105 Victoria St, London, SW1E 6QT or email firstname.lastname@example.org. The Code and other information, including details about ongoing cases, can be found on the PMCPA website www.pmcpa.org.uk.