Leo Pharma: missing clinical trial signposting and late patient organisation disclosure (AUTH/3418/11/20)

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Key facts

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Case number	AUTH/3418/11/20
Parties	Contactable pharmaceutical physician v Leo Pharma
Issue	Leo UK Disclosure and website issue (clinical trial signposting; patient organisation disclosures; website links; certification/recertification; Disclosure UK information)
Complaint received	11 November 2020
Case completed	18 November 2021
Applicable Code year	2019
Breaches	Clause 13.1; Clause 27.7; Clause 9.1
Clause 2	Panel ruled breach (for late 2019 patient organisation disclosure) but Appeal Board ruled no breach; final outcome: no breach of Clause 2
Sanctions	Undertaking received; Additional sanctions: Not stated
Patient organisations (2019 transfers noted)	Anticoagulation UK; National Eczema Society; Patients Association; Psoriasis Association
Timing detail	2019 patient organisation disclosures published in Dec 2020, more than 5 months later than required by the Code

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

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A pharmaceutical physician complained about multiple aspects of Leo Pharma’s UK corporate website (www.leo-pharma.co.uk) and related transparency/disclosure practices.
Clinical trials: The UK homepage did not include information on where details of Leo’s clinical trial results could be found (even though such information existed on Leo’s global site).
Patient organisation disclosures: Leo had made transfers of value to four patient organisations in 2019 but had not published the required disclosure by the deadline; Leo only identified the omission after receiving the complaint (Nov 2020) and published the disclosures in Dec 2020.
Website links: The complainant alleged users were redirected without notice; the Panel found the links were between Leo-owned sites and were sufficiently clear.
Old “News” items: The complainant alleged old press releases were patient/public educational material requiring certification/recertification and side effect reporting wording; the Panel considered them press releases intended for media and found no breach.
Disclosure UK: The complainant challenged how aggregated HCP numbers and certain HCO disclosures were presented and queried an apparent “joint working” entry; the Panel found no breach (including that the “joint working” entry was an erroneous categorisation of an R&D activity).

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Breach: Clause 13.1 (clinical trial details signposting on homepage).
Breach: Clause 27.7 (2019 Code) for late disclosure of 2019 transfers of value to patient organisations.
Breach: Clause 9.1 (high standards) in relation to the above breaches.
No breach: Clause 2 (Panel initially ruled a breach for late patient organisation disclosure, but this was overturned on appeal; final outcome was no breach of Clause 2).
No breach: Clauses 14.3, 14.5, 20, 24.1, 24.9, 26.3, 28.6 (as considered in the case).

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