Astellas UK: £50,000 hospital grant found inappropriately linked to Advagraf use; poor disclosure and investigation led to public reprimand (AUTH/2984/10/17)

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Key facts

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Case	AUTH/2984/10/17
Company	Astellas UK
Product	Advagraf (tacrolimus)
Complainant	Health professional (hospital doctor)
Allegation	Funding linked to adoption/use of Advagraf in a renal transplant immunosuppressive protocol; concerns about research funding and governance.
Key funding amounts	~£250,000 requested for two IDS (not paid); £50,000 MEGS paid to hospital special purpose fund (2010); additional invoice noted £2,500 (expert support) (paid to a third party).
Applicable Code	2008 edition
Clauses considered / ruled	Clause 2, Clause 9.1, Clause 18.5
Final breach finding	Breach of Clause 18.5, Clause 9.1 and Clause 2 (in relation to the £50,000 MEGS being inappropriately linked to Advagraf and poor standards/industry discredit).
No breach finding	No breach upheld regarding alleged IDS funding (no evidence funding provided for either IDS).
Sanctions	Undertaking received; public reprimand; advertisement; report to ABPI Board (ABPI Board: no further action).
Key dates	Complaint received: 13 October 2017; Undertaking received: 16 April 2018; Appeal hearings/considerations: 22 March 2018 and 20 June 2018; Panel reconvened: 12 June 2018; ABPI Board consideration: 4 September 2018.

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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A hospital doctor alleged Astellas UK inappropriately awarded research funding (~£250,000) in 2009 in association with use of Advagraf (tacrolimus) in a renal transplant protocol (Advagraf de novo, azathioprine, prednisolone).
Two investigator driven studies (IDS) were requested in April 2009 and were “approved in principle” by Astellas’ Investigator Driven Study Evaluation Committee (IDSEC) in May 2009, subject to questions.
Astellas said neither IDS proceeded and no IDS funds were paid.
Separately, a £50,000 payment to the hospital’s special purpose fund was made in 2010 as a medical and educational good and service (MEGS). Correspondence from the hospital described the £50,000 as permitting “implementation of a new clinical protocol using Advagraf in de novo live related kidney transplantation”.
On initial consideration, the Panel was concerned by the impression created but ruled (on balance) no breach regarding the £50,000 MEGS being linked to Advagraf.
On appeal, the Appeal Board found the cumulative evidence (dialogue, poor records, hospital linking the funds to Advagraf, lack of follow-up on use of funds) meant the MEGS did not satisfy requirements and was inappropriately linked to Advagraf.
During later re-audits, additional documents (including a November 2010 timeline and emails) emerged that had not been provided earlier. The Panel reconvened and raised very serious concerns about Astellas’ investigation and incomplete/misleading responses to the PMCPA.

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Outcome

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No breach was upheld in relation to the alleged £250,000 IDS funding (no evidence funds were provided for either study).
Breach was ruled in relation to the £50,000 MEGS payment: it was found inappropriately linked to use of Advagraf and did not meet MEGS requirements.
Further escalation occurred due to Astellas’ failure to properly investigate and disclose relevant documentation to the Panel and Appeal Board.
Astellas UK was publicly reprimanded and reported to the ABPI Board; the ABPI Board decided no further action beyond existing processes/re-audits.

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Astellas UK: £50,000 hospital grant found inappropriately linked to Advagraf use; poor disclosure and investigation led to public reprimand (AUTH/2984/10/17)

Key facts

What happened

Outcome

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