AUTH/2809/12/15: Sanofi Genzyme v Amicus Therapeutics – pre-authorisation promotion to a patient organisation meeting | PMCPA Case

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Key facts

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Case number	AUTH/2809/12/15
Parties	Sanofi Genzyme (complainant) v Amicus Therapeutics (respondent)
Issue	Promotion of migalastat (unlicensed at the time) to a patient organisation international network meeting; lack of formal certification
Setting	Patient organisation international network meeting, UK (November 2015)
Complaint received	10 December 2015
Case completed	11 April 2016
Applicable Code year	2015
Breach clauses	3.1, 9.1, 14.1, 14.3
No breach clauses	2, 26.1, 27.2
Key reasoning	Study protocol details plus “Next Steps” regulatory slide implied positive outcome and raised prospect of a new treatment; proactive provision to patient organisation leaders; presentation not formally certified
Sanctions	Undertaking received; additional sanctions not stated
Publication	Code of Practice Review, May 2016

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

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Sanofi Genzyme complained about a 30-minute Amicus Therapeutics presentation at a patient organisation international network meeting in the UK (November 2015) attended by patient organisation representatives, patients and health professionals.
The presentation referenced Amicus’s product migalastat, which did not have a marketing authorisation at the time.
Slides 21–25 described migalastat studies (including phase III) and included study design details such as dosage and/or endpoints (no clinical results were shown).
Slide 26 (“Next Steps for Migalastat”) stated the EMA review of the marketing authorisation application was “on track under accelerated assessment” and that a CHMP opinion was anticipated by early 2016—interpreted as implying a positive outcome.
The presentation was reviewed internally but was not formally certified before use; Genzyme also raised concerns about the absence of a UK reference number and signatory process.
Amicus argued it was “study awareness”/corporate/disease awareness, not promotion, and that much of the information was publicly available; it also cited temporary signatory absence due to sick leave.

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Breach: The presentation was ruled to have promoted migalastat prior to marketing authorisation (Clause 3.1).
No breach: Promotion to the public was not established in the context of this expert patient organisation meeting (no breach of Clause 26.1) and therefore no breach of Clause 27.2.
Breach: The presentation was not formally certified as required (Clauses 14.1 and 14.3).
Breach: High standards were not maintained (Clause 9.1).
Appeal: Appeal Board upheld breaches of Clauses 3.1, 14.1, 14.3 and 9.1; it overturned the Panel’s breach of Clause 2 (ruled no breach of Clause 2).

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