Teva v Chiesi: “Trouble-free” switching claim in Clenil journal ad ruled misleading and unsubstantiated

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Key facts

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Case number	AUTH/2313/4/10
Parties	Teva v Chiesi
Material	Clenil journal advertisement (ref CHCLE20100035)
Product / therapy area	Clenil (CFC-free beclometasone dipropionate inhaler) for asthma
Main issue	“Trouble-free” switching/transition claims implied switching to Clenil would be trouble-free for all
Key SPC point cited	Volumatic spacer must be used for certain adult/adolescent doses and for children/adolescents ≤15 years; spacer advised for coordination difficulties
Applicable Code year	2008
Complaint received	30 April 2010
Case completed	15 June 2010
Breach clauses	3.2, 7.2, 7.4, 7.5 and 7.10
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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Teva UK Limited complained about a journal advertisement for Clenil (CFC-free beclometasone dipropionate inhaler for asthma) issued by Chiesi Limited.
The ad headline was “Life’s full of disruptions. Changing to Clenil needn’t be one of them” and included the claims “Make the change to CFC-free beclometasone metered-dose inhalers trouble-free” and “CFC-free can be trouble-free”.
Teva alleged the claims were all-embracing, unqualified, misleading, exaggerated and not capable of substantiation, and did not reflect patient groups for whom switching would not be straightforward (eg those needing a Volumatic spacer per the Clenil SPC).
Teva said it requested substantiation but none was provided within the required timeframe.
Chiesi argued the claims were about proactive planning for the industry-wide transition away from CFC-containing inhalers and were not directed at a single brand.
The Panel concluded the overall message was that changing to Clenil would be trouble-free and that readers would associate the claims with Clenil.

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The claims “Make the change to CFC-free beclometasone metered-dose inhalers trouble-free” and “CFC-free can be trouble free” were ruled misleading, all-embracing and incapable of substantiation.
The Panel found the “trouble-free” implication was inconsistent with Clenil’s marketing authorisation because some patients would need to start using a Volumatic spacer on switching.
The Panel ruled that substantiation had been requested and not provided.
No appeal.

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