Chiesi: out-of-date SOP reviews led to breach, but no breach for HCP travel/hospitality or certification allegations (AUTH/3067/9/18)

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Key facts

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Case number	AUTH/3067/9/18
Parties	Member of the public v Chiesi
Issue	Payments to a health professional and certification; SOP governance and review timeliness
Complaint received	25 September 2018
Case completed	03 May 2019
Applicable Code year	2016
Allegations	Excessive hospitality/payments including business class flights; misuse of Zinc approval stamp; SOPs out-of-date/ignored/no ownership
Breach findings	Clause 9.1
No breach findings	Clause 2; Clause 9.1 (in relation to alleged excessive payments/expenses and alleged SOP non-compliance); Clause 14.1; Clause 22.1
Sanctions	Undertaking received
Appeal	No appeal
Published	May 2020 Code of Practice Review

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

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A member of the public (a friend of a Chiesi employee) complained about Chiesi’s compliance procedures and alleged excessive hospitality/payments to a named professor, including business class flights.
The complainant also alleged marketing material had been approved using the medical director’s Zinc approval stamp by an unauthorised employee.
The complainant alleged SOPs were ignored, had no clear ownership, and were largely out-of-date.
Chiesi investigated and provided flight/payment information for the professor since 1 August 2016, and information about its SOP system and audit/CAPA approach.
The Panel focused on whether the complainant had evidenced excessive hospitality/payments and whether SOP review controls were being followed.

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No breach for alleged excessive hospitality/business class flights to the professor (Clause 22.1 not breached).
No breach for alleged excessive/inappropriate payments and expenses to the professor (considered under Clause 9.1; no breach ruled on that aspect).
No breach for alleged misuse of the medical director’s approval stamp / inappropriate sign-off (no breach of Clause 14.1; and therefore no breach of Clauses 9.1 and 2 on that allegation).
Breach for failure to review and, if necessary, update SOPs promptly on or before their review dates, giving a poor impression and creating compliance risk (breach of Clause 9.1).
No breach of Clause 2 (Panel did not consider the circumstances warranted particular censure).

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