AUTH/2797/9/15: Anonymous health professional v Sanofi — APEX Barcelona meeting (Praluent/alirocumab) — No breach | PMCPA Case

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Key facts

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Case number	AUTH/2797/9/15
Complainant	Anonymous health professional (non-contactable)
Company	Sanofi
Meeting	APEX, Barcelona, 3–4 July 2015
Medicine referenced	Praluent (alirocumab)
Key allegation	Disguised promotion / promotion of alirocumab prior to marketing authorisation; “exception” for a UK investigator
UK affiliate involvement	Sanofi UK stated no involvement in organisation/arrangements; did not invite UK delegates; reviewed contractual arrangements for UK HCP engaged by European office
UK attendance	One UK health professional contracted by Sanofi European office as steering committee member/service provider; no UK delegates stated
Presentations mentioning alirocumab	Two of five presentations mentioned alirocumab; UK HCP presentation included a slide on ODYSSEY trial and alirocumab
Product regulatory status at meeting	Under EMA review; CHMP positive opinion 23 July 2015; European marketing authorisation September 2015
Clauses considered	2, 3.1, 9.1, 12.1, 18.1, 23.1
Panel decision	No breach of the Code
Complaint received	29 September 2015
Case completed	28 October 2015
Applicable Code year	2015
Appeal	No appeal

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

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An anonymous, non-contactable UK health professional complained about an invitation to attend the APEX meeting in Barcelona (3–4 July 2015).
The complainant said they were later told the meeting was cancelled for UK invitees because it was not compliant (medicine not licensed), but believed the meeting still went ahead for other countries.
The complainant alleged a UK colleague attended and spoke, and that the meeting was promotional about Praluent (alirocumab) prior to marketing authorisation, with an “exception” made because the doctor was an investigator.
Sanofi stated the meeting was organised by Sanofi’s European Medical Affairs group (Paris), with no involvement from Sanofi UK; no UK delegates attended and no Sanofi UK staff attended.
One UK health professional attended as a steering committee member/service provider contracted by the European office to oversee delivery, moderate workshops and give two presentations.
Panel noted that two of five presentations mentioned alirocumab, including a slide in the UK health professional’s presentation referencing the ODYSSEY trial and alirocumab.

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No breach of the Code was ruled.
The Panel did not consider alirocumab had been promoted to the UK health professional prior to marketing authorisation, on the narrow grounds of the complaint.
The Panel found no evidence the UK health professional was not suitably qualified or that the engagement was an inducement.
The Panel found no failure to maintain high standards and no discredit to the industry.

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