Public reprimand for Astellas UK

• Date posted
  17 December 2018
• Sanction
  Public reprimand,
• Case number/s
  AUTH/2984/10/17 - Health Professional v Astellas UK

Astellas Pharmaceuticals Limited has been publicly reprimanded by the Code of Practice Appeal Board for failing to provide accurate information to the Code of Practice Panel and the Appeal Board (Case AUTH/2984/10/17).

On appeal from the complainant, a hospital doctor, the Appeal Board overturned the Panel’s rulings and ruled breaches of the Code as it considered that a payment of
£50,000 to a hospital in 2010 by Astellas UK in relation to the assessment of a hospital treatment protocol was inappropriately linked to the use of a medicine. The medicine in question was Advagraf (tacrolimus) which was indicated to prevent rejection following kidney or liver transplantation.

Those carrying out the re-audits of Astellas in April 2018 in relation to three separate cases Cases AUTH/2780/7/15, AUTH/2883/10/16 and AUTH/2939/2/17, followed up the Appeal Board’s concerns at the appeal in Case AUTH/2984/10/17 that Astellas had provided limited documentation, about Astellas UK’s submission about the nature and depth of its investigation and that Astellas had not provided detailed accounts from two critical members of staff who were involved in all of the matters at issue and still employed by the company.

At the request of those carrying out the re-audits, a timeline showing key dates and decisions related to the payment in question was provided by an individual via the company’s normal process for supplying requested documentation. The timeline had not been previously disclosed as part of Astellas UK’s response to the PMCPA. The Panel reconvened and after further comment from Astellas it decided that, taking all the circumstances into account, including Astellas UK’s acknowledgement that it had failed to follow its processes for investigating complaints, it decided to report Astellas UK to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure.

In the Appeal Board’s view, notwithstanding the historical nature of the matters at issue, adopting basic principles of good governance and compliance practice, common sense and a positive cultural approach to transparency and disclosure should have facilitated more accurate responses and complete disclosure. That such an approach, apparently and on the evidence before the Appeal Board, was not consciously adopted at the outset was, in the Appeal Board’s view, and given Astellas’ recent compliance history, both inexplicable and inexcusable.

The Appeal Board was deeply concerned about the lack of rigour which Astellas had applied in conducting its investigation.

The Appeal Board considered that this case raised very serious matters including the historic issues relating to patient safety which were not the subject of the complaint and had not been considered or ruled upon as a discrete issue but arose as a coincidental matter during the consideration of the case. In addition, given the level of scrutiny the company was already under in relation to compliance, the Appeal Board was very concerned about the issues as set out above. Consequently, taking all the circumstances into account, the Appeal Board decided that in accordance with Paragraph 12.1 of the Constitution and Procedure, Astellas UK should be reported to the ABPI Board.

The ABPI Board considered the reputation of the industry to be of utmost importance, and therefore carefully considered all of the information before it. The ABPI Board concluded that although Astellas had made mistakes, in its view there was no malintent from the company to conceal. The ABPI Board noted the company’s submission that measures had now been taken to address the issues arising from this case. The ABPI Board noted Astellas UK’s submission that at no point were any patient safety issues caused by the conduct of Astellas and that the use of Advagraf within the treatment protocol was in line with the relevant summary of product characteristics. The ABPI Board further noted that patient safety was not the subject of the complaint.

The ABPI Board was already due to see the reports of the PMCPA’s 2019 re-audit of Astellas UK as a result of its consideration of re-audits in other cases. The failures identified in this case should be considered as a part of those re-audits. The ABPI Board would look closely at the report of the re-audits to ensure that it remained satisfied with the position of the company.

Taking everything into account, the ABPI Board decided that no further action was required.