Sanofi breached Clause 9.1 over use of 0845 number for medical information line (AUTH/3281/11/19)

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Key facts

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Case number	AUTH/3281/11/19
Parties	Member of the public v Sanofi
Topic	Responses to enquiries; accessibility of medical information telephone line
Complaint received	04 October 2019
Case completed	11 January 2021
Applicable Code year	2019
Medicines mentioned	Quadrivalent influenza vaccine (QIV); Dupixent (dupilumab); Approvel (irbesartan)
Main breach	Clause 9.1 (use of 0845 number for medical information service; potential deterrent effect and lack of cost transparency)
No breach findings	Clauses 7.2, 9.1 (other aspects), 15
Appeal	Sanofi appeal unsuccessful; breach of Clause 9.1 upheld
Sanctions	Undertaking received; additional sanctions Not stated

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

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What happened

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A member of the public complained about multiple interactions with Sanofi in 2019 involving medical information enquiries.
Issues raised included: alleged lack of response to a call (24 Sept 2019) about quadrivalent influenza vaccine (QIV) availability; alleged lack of response to an email (5 Sept 2019) about Dupixent (dupilumab) and compassionate use; alleged ignoring of a consultant letter; alleged GDPR breach; alleged inaccurate statements about whether the consultant had been informed; alleged untrue email about Approvel (irbesartan) supply; and use of an 0845 number for patient contact.
Sanofi said the 24 Sept call was to a named individual (not the medical information line), notes recorded no medical information query, and the matter was closed without escalation.
Sanofi said the 5 Sept email was escalated; the complainant was emailed on 6 Sept; and a Sanofi medical advisor spoke to the consultant on 6 Sept with a decision on compassionate use eligibility.
Sanofi said QIV availability was addressed in an email dated 20 Sept 2019, including directing HCPs/pharmacies to customer services to locate stock.
Sanofi said review of the 13 Sept call recording and written record found no personal data breach.
Sanofi said the 13 Aug email about Approvel 150mg being due for delivery to a wholesaler on 14 Aug 2019 was factually correct when sent.
Sanofi acknowledged 0845 numbers were perceived as premium rate, stated it received no revenue (service charge set to zero), and said it had a project to move to an 0800 freephone number; it later confirmed an 0800 number was live and being rolled out across materials.

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Outcome

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No breach was found for most allegations because the complainant did not establish the complaint on the balance of probabilities and/or Sanofi demonstrated it had responded.
Breach found: use of an 0845 number for the medical information service was held to fail to maintain high standards because it could deter callers and was not sufficiently accessible.
Sanofi appealed the Clause 9.1 breach; the Appeal Board upheld the breach (appeal unsuccessful).

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Key facts

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