AUTH/2865/8/16: Anonymous (non-contactable) v Sanofi — MEGS nurse advisor service (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2865/8/16
Parties	Anonymous, non-contactable complainant v Sanofi
Complaint received	03 August 2016
Case completed	19 December 2016
Published	February 2017 Code of Practice Review
Applicable Code year	2016
Allegations (summary)	Industry-funded audits/workshops leading to irregular product use; inducement/switching; coercive funding pressure via a health professional/consultancy company
Sanofi activity in scope	Patient management and nurse advisor service (MEGS) delivered by the consultancy company, early 2014 to 28 February 2015; Sanofi said it did not fund audits or the 2016 workshops
Panel decision	No breach of Clauses 2, 9.1, 18.1, 19.1, 19.2, 21, 23.1
Sanctions	None
Notable observation	Panel queried whether 14 representative visits in 2014 complied with Clause 15.4 call-frequency guidance (raised as a concern, not ruled as a breach in this case)

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

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An anonymous, non-contactable complainant alleged a therapy-area training/consultancy company (run by a health professional who also worked for NHS organisations and had prescribing responsibility/influence in a CCG) was involved in industry-funded audits and training that drove irregular use of sponsors’ products.
Allegations included patients being initiated/switched to sponsors’ medicines with little consideration of alternatives, and that industry funding for accredited workshops could be perceived as attempting to “buy the business”.
The complainant also alleged coercive behaviour: that pharmaceutical companies were told support was required or their products would not be used in the relevant CCG.
Sanofi stated it had only worked with the consultancy company on a patient management and nurse advisor service delivered as a medical and educational goods and service (MEGS) from late 2013/early 2014 to 28 February 2015, and had not funded audits or the 2016 workshops described.
The MEGS service involved specialist nurses assessing patients and reviewing treatment in line with locally agreed guidance; practices retained clinical responsibility for prescribing decisions.
Sanofi provided documentation (service operating procedure, contracts) and sales trend data which it said did not show disproportionate local increases linked to the service.

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No breach of the Code was ruled.
The Panel found the complainant provided no evidence and could not be contacted for further detail; the burden of proof was not met.
No breach was found in relation to inducement/switching concerns for the MEGS service.
No breach was found for clauses relating to audits/workshops where there was no evidence Sanofi engaged in the alleged activities.
The Panel noted a separate concern: Sanofi recorded 14 representative visits with the named health professional in 2014 (13 implied promotional) and queried compliance with Clause 15.4 (call frequency), asking that the company be advised of its views (not part of the breach rulings in this case).

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