Norgine v Movetis: “A new way out of chronic constipation in women” claim held misleading when unqualified inside leavepiece (Resolor)

📅 2008 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/2334/7/10
PartiesNorgine Pharmaceuticals Ltd v Movetis (UK) Limited
ProductResolor (prucalopride)
Indication (as stated)Symptomatic treatment of chronic constipation in women in whom laxatives failed to provide adequate relief
MaterialsA4 folder; A5 leavepiece; drop card
Main claim“At last! A new way out of chronic constipation in women” / “A new way out of chronic constipation in women”
Panel decisionBreaches ruled for folder, leavepiece and drop card
Appeal outcomeNo breach for A4 folder cover, A5 leavepiece front cover, and drop card; breaches upheld for A5 leavepiece internal pages (pages 2–3 spread/page 3 claim)
Breach clauses (final)3.2, 7.2, 7.10 (in relation to the unqualified claim on the leavepiece internal page)
Applicable Code year2008
Complaint received20 July 2010
Case completed2 November 2010
SanctionsUndertaking received; additional sanctions not stated

Download the full case report (PDF)


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

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What happened

  • Norgine complained about Movetis’ promotion of Resolor (prucalopride) using the headline claim: “At last! A new way out of chronic constipation in women”.
  • Resolor’s indication was: symptomatic treatment of chronic constipation in women in whom laxatives failed to provide adequate relief.
  • Materials at issue (picked up at a satellite symposium): an A4 folder, an A5 leavepiece and a drop card, all carrying the headline claim.
  • Norgine said the claim implied use in all women with chronic constipation (not just those who failed laxatives), making it inconsistent with the SPC, misleading, and exaggerating the product’s properties.
  • Movetis argued the full licensed indication was stated clearly and prominently and referenced MHRA pre-vetting of similar campaign material.
  • The Panel initially ruled breaches for all three items, focusing on “visual separation” between the headline and the qualifying indication.
  • Movetis appealed all rulings. The Appeal Board assessed each item’s layout and context separately.
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Outcome

  • A4 folder (cover): No breach — Appeal Board considered the reader’s eye would move quickly from headline to the full indication; rational use not undermined.
  • A5 leavepiece (front cover/page 1): No breach — same reasoning as the folder cover.
  • A5 leavepiece (opened out, pages 2–3): Breach upheld — page 3 included “A new way out of chronic constipation in women” followed only by “Rx prucalopride 1–2mg od”, without the key qualifier “in whom laxatives fail to provide adequate relief”.
  • Drop card: No breach — Appeal Board applied the same reasoning as for the folder cover.
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