Merz v Ipsen: Dysport ‘long-lasting effect’ campaign found misleading on appeal (AUTH/3228/7/19)

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Key facts

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Case	AUTH/3228/7/19
Parties	Merz Pharma UK Ltd v Ipsen UK Ltd
Product	Dysport (clostridium botulinum type A toxin)
Main issue	Promotion implying superior/unduly emphasised duration of effect; claim ‘Dysport – A toxin with a long-lasting effect’; post inter-company dialogue concerns
Evidence highlighted	Email exchange where a senior hospital pharmacist confirmed Merz’s summary of the March 2019 meeting account as accurate; lack of detailed Ipsen call notes
Panel decision	No breach (initially)
Appeal	By complainant (Merz)
Appeal Board decision	Breach Clauses 7.2, 7.10, 9.1; no breach Clause 7.3
Applicable Code year	2019
Complaint received	24 July 2019 (case report also states complaint received 25 July 2019)
Case completed	7 October 2020
Sanctions	Undertaking 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

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Merz Pharma UK Ltd complained about Ipsen UK Ltd’s promotion of Dysport (clostridium botulinum type A toxin), focusing on claims implying superior/sustained duration of effect.
Merz and Ipsen had previously completed inter-company dialogue (concluded December 2018) in which Ipsen undertook to withdraw materials containing certain duration-of-effect claims (including: ‘Dysport extends time to retreatment in some patients’ and ‘Dysport offers sustained effect of treatment up to 24 weeks in some patients for upper and lower limb spasticity’) and to brief sales/MSL teams that, absent comparative studies, no cross-trial comparisons could be made.
Post-dialogue, Merz alleged healthcare professionals continued to report Ipsen promoting a differentiation strategy based on sustained duration of effect, including an account (confirmed by a senior hospital pharmacist as accurately summarised by Merz) describing Ipsen arguing a Trust was disadvantaging patients by using an “inferior” product (Xeomin) versus Dysport with a longer duration of effect.
Ipsen said it had withdrawn the earlier materials, reserved the right to present licensed clinical data from the Dysport SPC, and that its current campaign included the claim ‘Dysport – A toxin with a long-lasting effect’, with briefing documents stating no comparisons should be made in the absence of head-to-head studies.
The Panel initially ruled no breach, citing limited evidence that representatives promoted longer duration versus other toxins.
Merz appealed. The Appeal Board focused on the main campaign claim ‘Dysport – A toxin with a long-lasting effect’, the lack of explanatory context/data strength in materials, the absence of head-to-head evidence, and the pharmacist-related evidence.

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Outcome

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Appeal Board found breaches of Clauses 7.2, 7.10 and 9.1.
No breach of Clause 7.3 (the Appeal Board did not consider it had evidence that the implied benefit amounted to a misleading comparison with Xeomin as alleged).
The Panel’s original “no breach” rulings were overturned on the above points.

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Key facts

What happened

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