AUTH/2872/9/16: Consultant oncologist and a pharmacist v Lilly (Oncology handbook) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2872/9/16
Parties	Consultant oncologist and a pharmacist v Eli Lilly & Company
Material	8th edition (2014) Handbook of Systemic Treatments for Cancer (Oncology handbook)
Main issue	Alleged misleading/unbalanced content due to omission of newly licensed medicines (eg, nivolumab; ramucirumab)
Company position	Non-promotional educational item; clear publication date and disclaimer; inclusion based on MIMS notifications up to end Nov 2013; omitted medicines approved after publication
Panel finding	Omissions not misleading/unbalanced given timing and clear dating/disclaimer; intended audience would expect new approvals after publication
Clauses considered	2, 7.2, 9.1
Outcome	No breach
Complaint received	12 September 2016
Case completed	9 November 2016
Appeal	No appeal
Applicable Code year	2016

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

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A consultant oncologist and a pharmacist complained about the 8th edition (2014) of Lilly’s Handbook of Systemic Treatments for Cancer.
They alleged the handbook was not up to date and therefore misleading/unbalanced because it omitted newly licensed medicines (examples given: nivolumab for lung cancer; ramucirumab for gastric cancer) while the handbook was being widely distributed and promoted.
This was a fresh complaint following a “new matter” raised during an earlier case about the same handbook (AUTH/2849/6/16).
Lilly said the handbook was a non-promotional educational item; the publication date (February 2014) was shown on pages and a prominent disclaimer directed users to check the SPC/eMC and not use out-of-date copies.
Lilly explained the editorial cut-off: medicines included were those notified to MIMS by end of November 2013; nivolumab and ramucirumab were not approved in the UK until April 2016 and December 2014 respectively.

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No breach of the ABPI Code of Practice (Applicable Code year: 2016).
No breach of Clause 7.2 (not misleading/unbalanced given clear publication date and the fact the omitted medicines were approved after the cut-off/publication).
No breach of Clause 9.1 (high standards) and no breach of Clause 2 (bringing discredit) in relation to the omission allegation.

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