LEO Pharma voluntary admission: undisclosed 2019 transfers of value to patient organisations (AUTH/3527/6/21)

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Key facts

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Case	AUTH/3527/6/21
Company	LEO Pharma UK (voluntary admission; payments made by LEO Pharma global organisation)
Issue	Undisclosed transfers of value to patient organisations in 2019; lack of certification for certain written agreements
Applicable Code year	2019
Patient organisations	Gorlin Syndrome Group; Lupus Europe; International Alliance of Patients’ Organisations (IAPO)
Transfers of value identified	1) Gorlin Syndrome Group R&D collaboration (Oct 2019) £12,469; 2) Gorlin Syndrome Group consultancy expenses (Jun 2019) £41.35; 3) Lupus Europe corporate partnership/advisory sessions (Mar 2019) 100,000 DKK; 4) IAPO congress sponsorship (activity Nov 2019; payment Apr 2020) €10,000
Panel findings (no breach)	Clause 27.7 (IAPO payment made in 2020 and disclosed by end June 2021); Clause 14.3 (two contracted-service agreements did not require certification)
Panel findings (breach)	Clause 27.7 (three 2019 payments disclosed late); Clause 14.3 (two non-contracted-service agreements not certified); Clause 9.1; Clause 2
Sanctions	Undertaking received; Advertisement
Complaint received	25 June 2021
Case completed	17 December 2021
Appeal	No appeal

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

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LEO Pharma UK made a voluntary admission after discovering that transfers of value (ToVs) made by the global organisation to UK-based patient organisations in 2019 had not been captured in UK disclosures.
The undisclosed ToVs related to three UK-headquartered patient organisations: Gorlin Syndrome Group, Lupus Europe and the International Alliance of Patients’ Organisations (IAPO).
LEO’s UK patient organisation disclosure list for 2019 was published late (December 2020) and updated (January 2021), but still did not include these cross-border ToVs.
The Panel found there were four ToVs connected to 2019 activities; one payment (to IAPO) was actually made in April 2020 and was disclosed as a 2020 ToV by end of June 2021.
Three payments made in 2019 (two to Gorlin Syndrome Group; one to Lupus Europe) were not disclosed by the end of June 2020 as required.
LEO provided four written agreements; two were for contracted services by patient organisations (and did not require certification), while two were not contracted services and had not been certified.
LEO stated that until end of 2020 it did not have an electronic approval system for cross-border activities that would automatically flag cross-border interactions/ToVs to the UK affiliate.

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No breach of Clause 27.7 in relation to the IAPO payment (because payment was made in April 2020 and disclosed by end of June 2021).
Breach of Clause 27.7 for failure to disclose three 2019 payments by end of June 2020.
No breach of Clause 14.3 for two agreements (Gorlin Syndrome Group consultancy expenses; Lupus Europe advisory sessions) because they were contracted services and did not need certification.
Breach of Clause 14.3 for two agreements (Gorlin Syndrome Group R&D collaboration agreement; IAPO congress sponsorship) because they were not contracted services and were not certified.
Breach of Clause 9.1 (high standards) due to failures around disclosure and certification processes.
Breach of Clause 2 (discredit to the industry), noted as a sign of particular censure, given repeated failures and lack of oversight of overseas interactions with UK patient organisations.

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No breach: Clause 14.3 (in relation to two contracted-service agreements); Clause 27.7 (in relation to the IAPO payment made in 2020).
Breach: Clause 2; Clause 9.1; Clause 14.3; Clause 27.7.
Not ruled: Clause 27.3 (Panel made no ruling; it considered certification under Clause 14.3 and noted no admission about contract content).

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