AUTH/2092/1/08: Bayer Schering v Lilly — Cialis alleged off-licence cardiovascular promotion (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2092/1/08
Complainant	Bayer Schering Pharma
Respondent	Eli Lilly and Company Limited
Medicine	Cialis (tadalafil)
Main allegation	Possible promotion of an unlicensed indication (cardiovascular-related) and unlicensed dosage; plus alleged failure to provide information/discuss conciliation
Evidence cited	Market research agency monitoring/detail recall reports (March 2007, September 2007, December 2007); three entries associating Cialis with cardiovascular effects from a small number of doctors
Applicable Code year	2006
Clauses considered	Clause 2, Clause 3.2, Clause 7.2, Clause 9.1
Panel decision	No breach of the Code
Complaint received	31 January 2008
Case completed	26 March 2008
Appeal	No appeal

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

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Bayer Schering Pharma complained that Eli Lilly may have promoted Cialis (tadalafil) for an unlicensed cardiovascular-related indication and an unlicensed dosage.
The complaint relied on market research agency “detail recall” monitoring reports (March 2007, September 2007, and later December 2007) suggesting some physicians associated Cialis with cardiovascular protection.
Bayer Schering asked Lilly to provide representative and speaker briefing materials to rule out direct/indirect involvement; Bayer Schering said Lilly would not provide the requested information and would not continue dialogue/conciliation.
Lilly denied off-licence promotion, stating all promotional materials were certified, training materials were certified (per Clause 15.9), and external speaker slides at promotional meetings were reviewed for medical accuracy.
Lilly challenged the reliability of the market research methodology (anonymous, recall-based, limited validation, uncertain uniqueness of respondents, no confirmation they were recently detailed).
The Panel reviewed Lilly’s promotional/briefing materials and noted they did not mention cardiovascular protection or doses other than 10mg and 20mg.

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No breach of the Code was found.
The Panel ruled Bayer Schering had not provided sufficient evidence, on the balance of probabilities, that Lilly promoted Cialis outside its licence in relation to cardiovascular conditions.
The Panel also ruled there was no breach regarding refusal to supply information or discuss conciliation; there is no obligation to discuss conciliation (only a requirement for the complainant to attempt inter-company dialogue before complaining).

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