AUTH/1935/12/06: PCT complaint about sponsored ‘Primary Care Report’ on CFC-free inhalers (No breach)

📅 2006 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/1935/12/06
ComplainantPrimary care trust assistant director of clinical services
CompanyTrinity-Chiesi Pharmaceuticals Ltd
MaterialPrimary Care Report, special edition 3 (December 2006), four pages, on CFC-free inhalers
Product mentionedClenil Modulite (beclometasone dipropionate, CFC-free)
Main allegationsDisguised promotion; one-sided content; technical inaccuracies; misleading/unreferenced DoH policy statement
Clauses considered7.2, 9.1, 10.1
DecisionNo breach of the Code
Complaint received19 December 2006
Case completed20 February 2007
Applicable Code year2006
AppealNo appeal
Sourcehttps://www.pmcpa.org.uk/cases/completed-cases/auth19351206-primary-care-trust-assistant-director-of-clinical-services-v-trinity-chiesi

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

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What happened

  • An assistant director of clinical services at a primary care trust complained about a four-page “special edition 3, December 2006” of Primary Care Report covering CFC-free inhalers.
  • The front cover stated: “This edition of Primary Care Report is sponsored by Trinity-Chiesi Pharmaceuticals Ltd”.
  • The front page headline was “Becotide/Becloforte withdrawal forces treatment reviews” and discussed transition to CFC-free beclometasone dipropionate (BDP).
  • Trinity-Chiesi’s product Clenil Modulite was described as a “CFC-free, dose equivalent alternative” to Becotide/Becloforte.
  • The complainant alleged the publication presented itself as “The first choice for primary care leaders” and read like “one long advertisement” for Clenil Modulite, being one-sided and containing technical inaccuracies.
  • The complainant challenged an unreferenced statement of Department of Health (DoH) policy: “CFCs will no longer be considered essential in products containing inhaled steroids in the UK once two alternative products containing beclometasone are available”, saying local strategic health authority advice required two preparations of equal potency and that generic BDP would remain available until then.
  • The complainant also said the publication did not mention switching to cheaper generic equivalents.
  • The Authority asked Trinity-Chiesi to respond in relation to Clauses 7.2, 9.1 and 10.1 of the Code.
  • Trinity-Chiesi said the item was clearly promotional (prominent sponsorship statement; prescribing information included; distributed via representatives) and that the DoH statement reflected the 1999 UK Transition Strategy and was capable of substantiation.
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Outcome

  • No breach of Clause 10.1 (disguised promotion) was ruled.
  • No breach of Clause 7.2 (misleading claims / substantiation) was ruled regarding the DoH policy statement.
  • No breach of Clause 9.1 was ruled (following the no-breach findings above).
  • Overall case outcome: No breach of the Code.
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