Alexion: PNH “guidance” on hospital website ruled disguised promotion of Soliris (AUTH/3356/5/20)

📊

Key facts

⌄

Case	AUTH/3356/5/20
Company	Alexion Pharma UK Ltd
Product	Soliris (eculizumab)
Issue	Alleged disguised promotion via PNH guidance document on a hospital website, including Soliris prescribing information and Alexion branding
Material	“Guidance for flow cytometric testing for GPI-deficient populations and Paroxysmal Nocturnal Haemoglobinuria (PNH)” dated October 2014; PI dated June 2014 on back page
Complainant	Concerned UK health professional
Complaint received	28 May 2020
Case completed	12 February 2021
Appeal	No appeal
Breaches	Clauses 4.3, 9.1, 12.1, 26.2
No breach	Clause 4.1
Sanctions	Undertaking received; additional sanctions not stated

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

A UK health professional complained about a PNH guidance document on a named hospital website (dated Oct 2014; ref UK/SPNH/12/0022(3)a).
The document appeared educational and stated it was supported by an “unrestricted educational grant” and “not influenced by Alexion”, but it also included Soliris prescribing information (dated June 2014) and Alexion branding/job bag code.
The complainant alleged the inclusion of prescribing information made it promotional and that the presentation attempted to disguise promotion.
The complainant also alleged the first mention of Soliris did not include the non-proprietary name and that the prescribing information was out of date.
Alexion accepted that, on balance, inclusion of prescribing information meant the material was promotional; it acknowledged breaches of Clauses 4.3, 9.1, 12.1 and 26.2, and denied a breach of Clause 4.1.
Alexion described efforts from May 2018 to early 2019 to have the material removed from the hospital website and from Google images; the Panel noted the complainant could still view it in May 2020.

⚖️

⌄

Breach of Clause 12.1 (disguised promotion) ruled.
Breach of Clause 4.3 (brand name not accompanied by non-proprietary name at most prominent mention) ruled.
Breach of Clause 26.2 (public-facing material could encourage public to ask for a POM) ruled.
No breach of Clause 4.1 (up-to-date prescribing information) ruled, on balance, because the complainant did not substantiate which SPC changes required PI changes.
Breach of Clause 9.1 (failure to maintain high standards) ruled due to prolonged availability online in the knowledge of some staff.
No appeal.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access