Alexion: LinkedIn ‘like’ treated as UK dissemination; pre-authorisation promotion breach upheld, but US press release ruled out of scope (AUTH/3163/2/19)

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Key facts

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Case	AUTH/3163/2/19
Parties	Concerned UK health professional v Alexion
Channel	LinkedIn post (US parent account) and linked press-release page
Products	ALXN1210 (unlicensed at the time); Soliris (eculizumab) referenced in press release
Main issue	UK employee “likes” treated as proactive dissemination; pre-authorisation promotion and certification
Applicable Code	2016
Complaint received	20 February 2019
Case completed	12 November 2019
Breach clauses	3.1; 14.1
No breach clauses	4.1; 4.9; 11.1; 26.1; 26.2; 26.3
Sanctions	Undertaking received; additional sanctions not stated

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

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A UK health professional complained about a LinkedIn post seen in their feed, originally raised in an earlier case (AUTH/3051/6/18).
The post (from Alexion’s US parent account) stated Alexion had submitted an EU application for approval of ALXN1210 for PNH and linked to a press-release page.
A small number of Alexion UK employees had “liked” the post; the Panel/Appeal Board treated this as proactive dissemination within the UK to the employees’ LinkedIn connections (likely including UK health professionals and members of the public).
The complainant alleged (among other points) that the post promoted an unlicensed medicine (ALXN1210) to health professionals and had not been certified.
The complainant also alleged the linked press release promoted Soliris to the public and to health professionals without prescribing information/AE reporting information.
Alexion argued the second complaint was procedurally unfair and that the press release was US-targeted and outside the Code’s scope (UK selection blocked access; US-resident disclaimer present).

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Breach upheld on appeal: Clause 3.1 (pre-authorisation promotion of ALXN1210 via the LinkedIn post as disseminated in the UK).
Breach upheld on appeal: Clause 14.1 (LinkedIn post not certified).
No breach on appeal: Clauses 4.1, 4.9, 11.1, 26.1, 26.2 (press release ruled outside scope of the Code due to US audience gating/disclaimer and indirect access route).
No breach (Panel): Clause 26.3 (side-effect reporting statement not required because the press release was not intended specifically for patients taking Soliris).
Appeal Board rejected Alexion’s procedural unfairness arguments and allowed the complaint to proceed as it raised different matters/clauses from the earlier case.

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