AUTH/2398/4/11: Director/Shire v Norgine – Movicol Paediatric Plain ‘NICE recommends… FIRST-LINE’ campaign (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2398/4/11
Parties	Director/Shire v Norgine
Company complained about	Norgine Pharmaceuticals Limited
Complainant	Shire Pharmaceuticals Limited
Product	Movicol Paediatric Plain (polyethylene glycol (macrogol) 3350 plus electrolytes)
Materials	Advertisement (MO/10/2014) and leavepiece (MO/2277/JAN/11)
Key claim	“NICE recommends MOVICOL Paediatric Plain FIRST-LINE*”
NICE guidance referenced	CG99 “Constipation in children and young people: Diagnosis and management of idiopathic childhood constipation in primary and secondary care”
Licensed ages stated in case	Chronic constipation: children 2–11 years; faecal impaction: from age 5 years
Complaint received	11 April 2011
Case completed	1 July 2011
Applicable Code year	2008
Outcome	No breach
Clause(s) cited	2, 3.2, 7.2, 7.6, 7.8, 7.10, 9.1, 9.6 and 25
Appeal	No appeal

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

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Shire complained about a journal advertisement (ref MO/10/2014; Paediatric Nursing, Nov 2010) and a leavepiece (ref MO/2277/JAN/11) for Movicol Paediatric Plain (polyethylene glycol (macrogol) 3350 plus electrolytes) issued by Norgine.
The materials used a prominent stamp-style claim: “NICE recommends MOVICOL Paediatric Plain FIRST-LINE*”.
Shire alleged the NICE “endorsement” was used without written permission from NICE (Clause 9.6).
Shire alleged the ad did not reference which NICE guidance was being relied upon (Clauses 7.6 and 7.8). Norgine confirmed it was NICE guideline CG99.
Shire alleged the claim and footnote (“…first line for the treatment of constipation and faecal impaction in children”) could imply use in younger children than the product’s licensed ages, given NICE CG99 includes dosing for under-1s and 1–5s but notes the product is not authorised for faecal impaction under 5 or chronic constipation under 2, and recommends informed consent for unlicensed use (Clause 3.2; plus Clauses 7.2 and 7.10).
Shire also alleged failures to maintain high standards / bringing industry into disrepute (Clauses 9.1 and 2), and asked the Panel to consider a breach of undertaking (Clause 25) linked to an earlier case (AUTH/2348/8/10).
For the leavepiece, Shire additionally argued Norgine had agreed (during inter-company dialogue) to suspend the campaign imagery/claims, yet a new leavepiece was prepared in Jan 2011 and used at a gastroenterology meeting in March 2011.

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No breach of the Code was ruled in relation to the advertisement and leavepiece.
The Panel ruled no breach of Clause 9.6 (NICE statement was not “reproduction of an official document”).
The Panel ruled no breach of Clauses 7.6 and 7.8 (the claim did not refer to a published study/artwork requiring a reference, though a reference would have been helpful).
The Panel ruled no breach of Clause 3.2 (not promoting outside the marketing authorisation), and no breach of Clauses 7.2 and 7.10 (not misleading; did not discourage rational use).
The Panel ruled no breach of Clauses 9.1 and 2 (since it did not find off-label promotion or lack of high standards).
The Panel ruled no breach of Clause 25 (no breach of undertaking; prior case material differed and the earlier undertaking did not apply as alleged).
On the inter-company dialogue point, the Panel noted the Constitution and Procedure did not require suspension of the materials; failure to suspend did not amount to a breach (no breach of Clauses 9.1 and 2).

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