Daiichi-Sankyo: call-rate briefing materials breached Clause 15.4 and 15.9 (AUTH/2857/7/16)

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Key facts

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Case	AUTH/2857/7/16
Complainant	Anonymous, non-contactable
Company	Daiichi-Sankyo UK
Main issues	Emails without prescribing information; training/validation; market access and MSL call arrangements; call rates/targets
Products mentioned	Lixiana (edoxaban); competitor product Xarelto (rivaroxaban)
Applicable Code year	2016
Complaint received	1 July 2016
Case completed	30 September 2016
Appeal	No appeal
No breach clauses	Clause(s) 2, 3.1, 3.2, 4.1, 9.1, 14.1
Breach clauses	Clause(s) 15.4, 15.9
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous, non-contactable complainant raised four issues about Daiichi-Sankyo UK’s promotional activities and call rates.
Allegation 1: market access consultants sent emails to customers (including competitor references) without prescribing information; an example email exchange discussed an NHS NOAC patient leaflet and rivaroxaban dosing/food instructions.
Allegation 2: new staff were said to be completing validation examinations before product training (a hospital sales manager was named).
Allegation 3: market access staff were said to be insisting on “promotional calls” alongside medical liaison scientist (MLS/MSL) appointments.
Allegation 4: following territory/geography changes, the company introduced activity expectations (healthcare outcomes managers: 3 calls/day and 4 contacts/day; hospital: 4 calls/day and 6 contacts/day) with alleged threats of PIPs/disciplinary action if not met.

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No breach for the email allegations: the Panel did not consider the cited email exchange to be promotion and therefore it did not require prescribing information or certification.
No breach for the training allegation: the complainant did not prove, on the balance of probabilities, that training/validation was in breach.
No breach for the joint call allegation: the Panel was concerned about the described arrangements but the complainant did not prove the allegation on the balance of probabilities.
Breach for call-rate briefing materials: the Panel found the expected call/contact rates were not defined or clearly distinguished and were not set in the context of Code limitations, indirectly advocating behaviour likely to breach the Code.

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