AUTH/2868/8/16: Janssen-Cilag v Sanofi Genzyme — EULAR stand held to indirectly promote unlicensed sarilumab (IL‑6 focus) | PMCPA Case

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Key facts

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Case	AUTH/2868/8/16
Parties	Janssen-Cilag v Sanofi Genzyme
Issue	Alleged promotion of an unlicensed medicine (sarilumab) via IL-6-focused congress activity
Event	EULAR Congress of Rheumatology, London (June 2016)
Medicine	Sarilumab (IL-6 receptor blocker), unlicensed at the time
Key activity cited	Large branded exhibition stand exclusively about IL-6 in rheumatoid arthritis (claims, interactive videos, monographs/handouts, touchscreens; medical corner)
Applicable Code year	2016
Breach clauses	Clause 3.1; Clause 9.1
Appeal	Appeal by respondent; unsuccessful (breaches upheld)
Complaint received	11 August 2016
Case completed	3 February 2017
Sanctions (published)	Undertaking received; Additional sanctions: Not stated

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

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Janssen complained that at the EULAR Congress of Rheumatology (London, June 2016) Sanofi Genzyme promoted its forthcoming IL-6 receptor blocker, sarilumab, before it had a marketing authorization.
The complaint focused on a large, prominently branded Sanofi Genzyme/Regeneron exhibition stand that was exclusively about IL-6 in rheumatoid arthritis, using bold statements, interactive videos, touchscreens and “educational monographs/handouts”.
Sanofi Genzyme also sponsored a symposium on IL-6 (which included discussion of IL-6 inhibition and referenced sarilumab) and there were posters/abstracts on sarilumab at the same congress (Janssen said it was the overall context, not the posters/symposium per se).
Staff briefing materials stated sarilumab was investigational/unlicensed and must not be proactively discussed; if asked, delegates should be referred to scientific advisers/MSLs or medical personnel in a medical area of the stand.
The Panel and Appeal Board assessed the stand in the context of the company’s other IL-6 activities at the congress and the proximity to regulatory submissions (US application accepted earlier in 2016; EU application accepted for review in July 2016).

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Breach of Clause 3.1 ruled: the exhibition stand activity (in context) was held to indirectly promote/prepare the market for an unlicensed medicine (sarilumab) and to solicit questions about it.
Breach of Clause 9.1 ruled: high standards had not been maintained (linked to the pre-licence promotion finding).
Sanofi Genzyme appealed both rulings; the Appeal Board upheld both breaches and the appeal was unsuccessful.

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