Astellas voluntary admission: transfers of value not disclosed to HCOs and patient organisations (2019–2021)

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Key facts

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Case	AUTH/3680/8/22
Company	Astellas Pharma Ltd
Case type	Voluntary admission
Issue	Undeclared transfers of value (HCO and patient organisation disclosures)
Recipients involved	HCOs: European Renal Association (ERA); International Continence Society (ICS). Patient organisations: Kidney Research UK; Leukaemia Care; Kidney Care UK; Prostate Cancer UK; Duchenne UK.
Time period	2019–2021 (identified in 2022)
Key amounts mentioned	ERA: £39,440 (2019), £84,899 (2020), £53,859 (relating to 2021); ICS: £58,523 (2021); Kidney Research UK: £350 (2020); Leukaemia Care: £725 (2021); Kidney Care UK: £67 (2021); Prostate Cancer UK: £75 (2021); Duchenne UK: £15,000 (2021).
Root cause described	Human error in vendor identifier selection and/or GL code selection; misclassification of an organisation as a third-party vendor; incorrect GL codes for PO payments so they did not pull through to disclosure.
Applicable Code year	2021 (with breaches also under 2019 Code clauses for earlier years)
Complaint received	4 August 2022
Case completed	18 July 2023
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions not stated

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

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What happened

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Astellas made a voluntary admission about undeclared transfers of value (ToVs) to healthcare organisations (HCOs) in 2019, 2020 and 2021 and to patient organisations (POs) in 2020 and 2021.
The issue was found during routine monitoring of group (non-Astellas Pharma Ltd) interactions; an error identified for a 2022 interaction led to a wider investigation of 2019–2021 disclosures.
HCO ToVs were not disclosed on the ABPI Disclosure Portal due to set-up/classification and accounting coding issues (Vendor Identifier selection and/or General Ledger (GL) code selection) meaning payments did not “pull through” into UK disclosure outputs.
PO payments were not disclosed on Astellas’ website because incorrect GL codes were used when setting up PO payments, so they did not pull through to the UK disclosure templates.
Undisclosed recipients and examples included:
- European Renal Association (ERA): sponsorship for ERA Congress in 2019 (£39,440) and 2020 (£84,899), and a further payment relating to 2021 (£53,859).
- International Continence Society (ICS): sponsorship for ICS Conference in 2021 (£58,523) (paid via a third-party congress organiser, but ICS was the recipient).
- Kidney Research UK: £350 (speaker service for internal disease awareness educational event for World Kidney Day, 2020).
- 2021 PO payments: Leukaemia Care (two payments; one described as £725 for speaker services for ‘AML at home’ video series), Kidney Care UK (£67), Prostate Cancer UK (£75), Duchenne UK (£15,000 sponsorship for educational material).
Astellas stated it implemented a corrective and preventive action (CAPA) plan and updated/resubmitted disclosure templates for 2020 and 2021 on its website.

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Outcome

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Breach found for late/non-public disclosure of ToVs to HCOs under the 2019 Code (ERA 2019 and 2020) and under the 2021 Code (ERA and ICS 2021).
Breach found for non-disclosure of ToVs to patient organisations under the 2019 Code (Kidney Research UK 2020) and under the 2021 Code (five undisclosed 2021 PO payments).
Overall breach of Clause 5.1 (2021 Code) for failing to maintain high standards, given transparency is an important part of self-regulation and the failures spanned multiple years.
No breach of Clause 2 (2021 Code) (Panel considered Clause 5.1 breach sufficient in the circumstances).
No appeal.

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Clauses

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Breach of Clause 24.1 Failure to publicly disclose certain transfers of value made directly to healthcare organisations located in Europe
Breach of Clause 24.4 Failure to disclose transfers of value annually within the first six months after the end of the calendar year in which the transfers of value were made
Breach of Clause 27.7 Failure to disclose transfers of value to a patient organisation that must be done within the first six months after the end of the calendar year in which the transfers of value were made
Breach of Clause 28.1 Failure to publicly disclose certain transfers of value made directly to healthcare organisations located in Europe
Breach of Clause 31.1 Failure to disclose transfers of value annually within the first six months after the end of the calendar year in which the transfers of value were made
Breach of Clause 29.1 Failure to publicly disclose transfers of value to a patient organisation
Breach of Clause 31.1 Failure to disclose transfers of value to patient organisations annually within the first six months after the end of the calendar year in which the transfers of value were made
Breach of Clause 5.1 Failing to maintain high standards
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

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Key facts

What happened

Outcome

Clauses

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