LEO Pharma UK – Undeclared transfers of value (Disclosure UK) (AUTH/3593/12/21) | PMCPA Case

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Key facts

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Case number	AUTH/3593/12/21
Company	LEO Pharma UK (voluntary admission; payments made by Leo Pharma A/S)
Issue	Undeclared transfers of value for 2020 (five ToVs omitted from UK 2020 disclosure)
Recipients	4 health professionals; 1 healthcare organisation (British Association of Dermatology)
Activities	Congress sponsorship (HCO); advisory board member payments (HCPs)
Payment dates	November 2020 (4/11/2020; 11/11/2020; 18/11/2020; 25/11/2020)
Amounts	£30,000 (HCO); £1,875; £930; £375; £1,350 (HCPs)
Root cause	Human error in global upload; Excel report remained in “pending remediation” due to lack of oversight
Corrective actions	Updated and re-submitted 2020 disclosure; system upgrade; re-training; new cross-border engagement system to enable affiliate cross-checking
Applicable Code	2019
Breach clauses	Clause 24.1
Complaint received	17 December 2021
Case completed	17 October 2022
Appeal	No appeal
Sanctions	Undertaking received; additional sanctions: Not stated

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

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LEO Pharma UK submitted its 2020 transfers of value (ToV) disclosure data to Disclosure UK in March 2021.
In December 2021, LEO’s global healthcare compliance team notified LEO Pharma UK that five UK ToVs from November 2020 (four to health professionals and one to a healthcare organisation) were missing from the UK 2020 disclosure document.
The payments had been made by Leo Pharma A/S (global organisation) and were not fully processed into LEO’s transparency system due to a human error and lack of oversight: an Excel report for November 2020 remained in “pending remediation” rather than being fully processed.
The missing ToVs were identified by the global team on 30 November 2021 and submitted to Disclosure UK on 17 December 2021.
LEO updated the 2020 transparency report to include the omissions and re-submitted it to the ABPI disclosure platform.

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Breach found: Yes.
The Panel ruled a breach of the Code in relation to the five undisclosed payments.
No appeal.

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