UCB employee LinkedIn profile promoted unlicensed bimekizumab (AUTH/3287/12/19)

📊

Key facts

⌄

Case number	AUTH/3287/12/19
Case reference	Employee v UCB – Personal LinkedIn Profile
Complainant	Anonymous, non-contactable UCB employee
Respondent/company	UCB
Product(s)	Bimekizumab (unlicensed; Phase 3 development for axial spondyloarthritis/axial spondyloarthropathy)
Material/channel	Personal LinkedIn profile (openly accessible)
Key issue	Statement on LinkedIn naming an unlicensed medicine and an indication; whether this was promotional and required certification
Dates (received/completed if stated)	Complaint received: 13 December 2019; Case completed: 27 March 2020
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Breach: 3.1, 14.1, 9.1. No breach: 4.1, 4.9, 4.10, 26.1, 26.2, 2.
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

📋

⌄

An anonymous, non-contactable UCB employee complained about a colleague’s openly accessible personal LinkedIn profile.
The profile described the colleague’s role at UCB as: “Supporting Phase 3 programme in axial spondyloarthropathy for bimekizumab”.
The complainant alleged this could generate pre-licence interest and that the colleague’s network appeared to include health professionals and the general public.
The complainant queried whether the statement had been certified and raised concerns about missing prescribing information/black triangle/adverse event reporting statements.
UCB said the wording was created independently by the individual without UCB’s instruction or knowledge; UCB asked the individual to remove it during its internal investigation.
UCB stated bimekizumab was unlicensed and in Phase 3 development for axial spondyloarthritis, with a potential marketing authorisation in that indication expected in 2023.

⚖️

⌄

The Panel ruled the statement promoted an unlicensed medicine because it included the medicine name and an indication.
Breach ruled: Clause 3.1 (promotion of an unlicensed medicine).
Breach ruled: Clause 14.1 (material not certified).
No breach ruled: Clause 4.1 (prescribing information not relevant for an unlicensed medicine with no SPC).
No breach ruled: Clauses 4.9 and 4.10 (adverse event reporting statement and black triangle not relevant given the medicine was unlicensed and not available to prescribe outside clinical trials).
No breach ruled: Clauses 26.1 and 26.2 on a narrow technical point because the clauses apply to prescription only medicines and the unlicensed medicine was not classified as such.
Breach ruled: Clause 9.1 (high standards not maintained).
No breach ruled: Clause 2 (although the Panel noted the seriousness and potential for Clause 2, it decided on balance there was no breach given the professional networking context and likely professional interest of viewers).

📖

⌄

Clause 3.1 – Breach (statement promoted an unlicensed medicine by naming bimekizumab and an indication).
Clause 14.1 – Breach (statement had not been certified).
Clause 9.1 – Breach (high standards not maintained).
Clause 4.1 – No breach (prescribing information requirement not relevant for an unlicensed medicine with no SPC).
Clause 4.9 – No breach (AE reporting statement requirement not relevant in the circumstances).
Clause 4.10 – No breach (black triangle requirement not relevant in the circumstances).
Clause 26.1 – No breach (applies to prescription only medicines; unlicensed medicine not classified as such).
Clause 26.2 – No breach (applies to prescription only medicines; unlicensed medicine not classified as such).
Clause 2 – No breach (Panel considered potential but ruled no breach on balance).

🔒

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