Servier: MLS email trail seen as off-licence promotion of Procoralan (ivabradine) for heart failure (AUTH/2417/6/11)

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Key facts

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Case	AUTH/2417/6/11
Parties	Primary Care Trust Head of Medicines Management v Servier
Product	Procoralan (ivabradine)
Issue	Alleged promotion for unlicensed indication (heart failure) via MLS emails and related activity
Complaint received	14 June 2011
Case completed	10 October 2011
Applicable Code year	2011
Final breach clauses	3.2; 9.1 (x2)
Clauses not upheld (on appeal)	2; 15.2
Sanctions	Undertaking received; Additional sanctions: Not stated
Core evidence	Email stating cardiologists’ responses were “very positive” and some were already using ivabradine “off licence” in heart failure; no discussion of budgetary implications in that email

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

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What happened

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A PCT head of medicines management complained that Servier promoted Procoralan (ivabradine) for an unlicensed indication (heart failure). Procoralan was licensed for chronic stable angina.
The complaint was triggered by an email chain between a Servier medical liaison specialist (MLS) and NHS contacts about heart failure pathways/audits and ivabradine.
The MLS stated he was not sales and that his role was to deal with non-licensed indications; he referenced Servier’s application for a heart failure indication and said local cardiologists’ responses were “very positive”, with some already using ivabradine “off licence” in heart failure.
The MLS invited a meeting to discuss heart failure, ivabradine and the patient pathway and offered to bring “data and modelling tools”.
The medicines management lead pharmacist replied that ivabradine would need to be licensed before funding; highlighted SPC contraindications/cautions in heart failure and raised cost concerns (estimated ~£75,000/year plus “therapeutic creep”).
Servier said the email communication was unclear/ambiguous and accepted it fell below its standards; it argued the intent was advanced budgetary notification and not promotion.
Panel concerns included: proactive outreach (not limited to unsolicited enquiries), advanced notification conditions not met (no stated significant budget impact/costs in the access letter), and omission of contraindication/caution context in the emails.
On appeal, the Appeal Board distinguished between (a) the company’s overall activity and (b) the specific MLS email(s).

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Outcome

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Breach upheld: Clause 3.2 (promotion of an unlicensed indication) in relation to the MLS email(s).
Breach upheld: Clause 9.1 (high standards) (x2).
No breach (on appeal): Clause 2 (Appeal Board did not consider Clause 2 warranted).
No breach (on appeal): Clause 15.2 (Appeal Board found MLSs were not “representatives” as defined, so the clause did not apply).
The Panel had reported Servier to the Appeal Board under Paragraph 8.2, but after the appeal outcome the Appeal Board decided to take no further action in relation to that report.

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Key facts

What happened

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