What happened

• 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.

Outcome

• 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).

Clauses

• 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).

Sanctions

• No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report
• UCB stated it asked the individual to remove the information from the LinkedIn profile during the internal investigation.
• UCB stated it would re-emphasise existing guidance and take actions including highlighting internal speak-up channels at an all-employee meeting, monitoring its social media policy, and revising induction to include appropriate personal use of social media.

ABPI signatory lens

Why this matters: Personal social media can become “promotion” under the Code when it links a company, a medicine name and an indication—especially pre-licence—creating regulatory and reputational risk even if the employee acts independently.

Where teams typically slip up (interpretation):

• Assuming “personal account” means “outside the Code”, particularly on professional platforms like LinkedIn.
• Using development-stage product names plus disease/phase language that reads as pre-licence promotion.
• Relying on privacy settings/limited dissemination arguments instead of preventing the content in the first place.

The control that would have prevented it: A clear, mandatory social media standard for all staff/contractors that prohibits naming unlicensed medicines with indications on personal profiles, backed by onboarding training and periodic attestations.

What I’d check in an audit:

• Onboarding materials and training completion records covering personal social media and pre-licence communications.
• Written policy/guidance that explicitly addresses LinkedIn profiles (job descriptions, “about” sections, experience entries) and unlicensed medicines.
• Evidence of monitoring/escalation routes and how quickly potentially promotional personal posts are remediated once identified.
• Certification SOP scope: how the organisation decides what requires certification and how staff are instructed to seek advice.

What the sanctions tell you (interpretation):

• The case was treated as serious on principle (unlicensed promotion), but context mattered (professional networking site) in avoiding Clause 2.
• Remediation expectations focus on prevention through training, guidance and speak-up channels rather than punitive measures.
• Even minimal wording can trigger breaches if it connects product name + indication pre-licence.

3 questions to ask your team this week:

1. Do our employees/contractors know what they can and cannot say about pipeline products on LinkedIn profiles?
2. Do we have a simple route for staff to get rapid compliance advice on personal social media content?
3. Are our onboarding and refresher trainings explicit about “product name + indication” being high-risk pre-licence content?

Key facts

Download the full case report (PDF)

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