AUTH/2365/10/10: Anonymous v Sanofi-Aventis — ‘Oncology Product Pipeline Update’ (advance notification) sent to sales reps in error (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2365/10/10
Parties	Anonymous v Sanofi-Aventis
Material	Document: “Oncology Product Pipeline Update” (front stated “Advanced Notification”)
Main allegation	Provided to sales representatives to promote/discuss upcoming unlicensed products
Products	Five medicines (names not stated)
Key compliance issue	Risk of promotion of unlicensed medicines via advance-notification/pipeline document; distribution error to sales reps
Company position	Document intended for oncology healthcare specialists for NHS budget planning; sales reps received it in error; internal-only note; swift withdrawal and confirmed returns
Clauses considered	2, 3.1, 3.2, 9.1
Panel decision	No breach of Clauses 3.1 and 3.2; therefore no breach of Clauses 2 and 9.1
Panel observations	Concern about multiple copies; suggested clearer “must not discuss externally” instruction; serious concern whether document met Clause 3.1 supplementary information (eg, budget implications not quantified; timing queried); concern about non-promotional role description
Complaint received	19 October 2010
Case completed	5 November 2010
Applicable Code year	2008
Appeal	No appeal

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

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What happened

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An anonymous, non-contactable complainant alleged Sanofi-Aventis provided a document titled “Oncology Product Pipeline Update” to oncology sales representatives to promote and discuss upcoming new products that did not have licences.
The document front cover described it as “Advanced Notification” intended for national horizon scanning organisations, NHS managers and other professionals responsible for planning/commissioning cancer services.
The document covered five medicines and included: anticipated marketing indication, EU/UK licence status, administration, whether replacement/addition to other options, estimated cost per patient course, service implications, eligible patients, evidence base and NICE status.
No actual acquisition costs were provided (not yet determined); it stated annual cost was expected to be in line with other recently launched innovative cancer therapies.
Sanofi-Aventis said the document was prepared for exclusive use by oncology healthcare specialists (a team formed in September 2010) to provide advance budget-impact information to NHS policy/budget decision-makers.
Due to an administrative error, oncology sales representatives were sent 1–3 copies each on 23 September 2010; the accompanying email said it was “for information internally only”.
Sanofi-Aventis said reps were not directed or trained to use it and were told it was for their own information only.
Sanofi-Aventis became aware of the distribution error on 14 October 2010 and initiated withdrawal and an internal investigation before the complaint was received; written confirmation of return was obtained from all oncology sales representatives.

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Outcome

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The Panel found, on the information before it, that representatives had not been instructed to promote unlicensed medicines.
The Panel did not consider it unacceptable to send the document to representatives, but queried why multiple copies were sent (which could imply onward distribution).
The Panel said it would have been helpful if the covering note had clearly stated that representatives must not discuss the document with anyone they called upon.
The Panel did not consider that representatives had promoted unlicensed indications or unlicensed products.
No breach of the Code was ruled (including no breach of Clause 2).
The Panel was extremely concerned about the document’s content and advised Sanofi-Aventis to ensure it met all elements of the relevant supplementary information to Clause 3.1 (Advance Notification of New Products or Product Changes).

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AUTH/2365/10/10: Anonymous v Sanofi-Aventis — ‘Oncology Product Pipeline Update’ (advance notification) sent to sales reps in error (No breach)

Key facts

What happened

Outcome

Clauses

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