AUTH/3285/12/19: Ex-employee v Daiichi-Sankyo – Underreporting transfers of value on Disclosure UK | PMCPA Case

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Key facts

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Case number	AUTH/3285/12/19
Case reference	Ex-employee v Daiichi-Sankyo
Complainant	Ex-employee
Respondent/company	Daiichi-Sankyo
Product(s)	Not stated
Material/channel	Disclosure UK (transfers of value disclosures)
Key issue	Omitted/underreported transfers of value for HCP sponsorship to attend conferences (including indirect ToVs via third parties) across 2016–2018; inadequate processes and record retention
Dates (received/completed if stated)	Complaint received: 30 November 2019; Undertaking received: 13 February 2020; Interim case report first published: 1 September 2020; Case completed: 23 February 2023
Appeal	Complainant appealed the ruling of no breach of Clause 24.10; appeal unsuccessful and no breach upheld
Code year	2019 Code (Panel considered the case under the 2019 Code; noted 2016 Code also applied to the time period)
Breaches/clauses	Breach: Clauses 2, 9.1, 22.5, 24.1, 24.4, 24.6, 24.7, 24.9; No breach: Clause 24.10
Sanctions	Public reprimand; audit required; subsequent re-audits (September 2020 audit; re-audits May 2021, March 2022, November 2022); ultimately no further action required

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What happened

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An ex-employee complained that Daiichi-Sankyo’s 2018 Disclosure UK entries showed healthcare professional registration fees of £7,937.60 for named individuals and zero in aggregate, which the complainant alleged was gross underreporting.
The complaint focused on sponsorship for the European Society of Cardiology (ESC) congress in Munich, Germany (August 2018), alleging the company sponsored around 100 healthcare professionals and paid travel, accommodation, food and registration fees, but many individuals could not be found on Disclosure UK and aggregated reporting was zero.
Daiichi-Sankyo submitted it funded flights, accommodation and congress registration for 98 health professionals for ESC 2018; and paid travel, accommodation and registration fees for 28 health professionals for ESC 2017 and 15 for ESC 2016.
Daiichi-Sankyo acknowledged that the relevant transfers of value for these congress attendances were not reported on Disclosure UK (neither individually nor in aggregate).
Daiichi-Sankyo said the omission related to indirect transfers of value where administration/logistics were contracted to a third party; the supporting file with per-HCP transfer-of-value details was either not provided by the third party or not formally requested by Daiichi-Sankyo at the time.
The company described weaknesses in its review process, including reliance on financial system reports that did not contain itemised HCP transfer-of-value data for these activities, and lack of sign-off by departmental heads with budget responsibility; it also cited lack of training and absence of an SOP at the time (an SOP was prepared after the complaint was received).
When asked to quantify unreported transfers of value for 2018–2016, Daiichi-Sankyo stated it did not have complete visibility, but identified around £471,000 as unreported across events/years (including ESC 2018, ESOC 2018, ETNA 2018, ESC 2017, ESC 2016).

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Outcome

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The Panel ruled that the information published on Disclosure UK at the time of the complaint was not comprehensive for conference support in 2018, 2017 and 2016.
The Panel ruled breaches of Clauses 22.5, 24.1, 24.4, 24.7 and 24.9 (as acknowledged by Daiichi-Sankyo) in relation to omitted transfers of value and failure to disclose by the required deadline, including failure to disclose either individually or in aggregate.
The Panel ruled a breach of Clause 24.6 (record retention/documentation), finding Daiichi-Sankyo had not been able to produce all relevant data and noting inconsistencies, despite the company’s denial.
The Panel ruled no breach of Clause 24.10 (methodological note), and this was upheld on appeal because there was insufficient evidence to establish a breach.
The Panel ruled breaches of Clause 9.1 (high standards) and Clause 2 (bringing discredit), citing the scale and seriousness of the underreporting and inadequate processes.
The Panel reported Daiichi-Sankyo to the Appeal Board under Paragraph 8.2 of the Constitution and Procedure due to concerns about the company’s procedures.
The Appeal Board concluded there was a fundamental and systemic failure of processes and a misunderstanding of Code requirements over a three-year period, and decided Daiichi-Sankyo should be publicly reprimanded and required to undergo an audit of its procedures in relation to the Code.
Following audits and re-audits (September 2020; May 2021; March 2022; November 2022), the Appeal Board ultimately decided that no further action was required (on the basis improvements continued and commitment to compliance was maintained).

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Clauses

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Clause 2 – Breach ruled (particular censure due to failure to disclose required information and scale of underreporting; inadequate process).
Clause 9.1 – Breach ruled (high standards not maintained).
Clause 22.5 – Breach ruled (omitted 2018, 2017 and 2016 data).
Clause 24.1 – Breach ruled (failure to document and publicly disclose transfers of value).
Clause 24.4 – Breach ruled (failure to disclose by 30 June of the relevant year).
Clause 24.6 – Breach ruled (documentation/record retention for 5 years).
Clause 24.7 – Breach ruled (failure to disclose transfers of value to individuals or in aggregate, as applicable).
Clause 24.9 – Breach ruled (failure to disclose transfers of value to individuals or in aggregate, as applicable).
Clause 24.10 – No breach ruled (methodological note requirement met; no evidence provided to establish breach; upheld on appeal).

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AUTH/3285/12/19: Ex-employee v Daiichi-Sankyo – Underreporting transfers of value on Disclosure UK

Key facts

What happened

Outcome

Clauses

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