Novo Nordisk: delayed disclosure of one Tresiba Phase III trial (AUTH/2906/11/16)

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Key facts

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Case	AUTH/2906/11/16
Parties	PMCPA Director v Novo Nordisk
Issue	Clinical trial disclosure (Tresiba / insulin degludec)
Complaint received	06 December 2016
Completed	14 March 2017
Applicable Code year	2012 (Second 2012 Code; Joint Position 2009 referenced)
Product first licensed/commercially available (UK)	21 January 2013
Key breach finding	Late disclosure for trial NN1250-3561
Clauses considered	13.1, 9.1, 2
Outcome	Breach of Clauses 13.1 and 9.1; no breach of Clause 2
Sanction	Undertaking received
Appeal	No appeal

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

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A CMRO paper (ABPI-funded) assessed whether results of company-sponsored trials for EMA-approved 2013 medicines were disclosed within 12 months of the later of first regulatory approval or trial completion (search window 1 May–31 July 2015).
The PMCPA Director opened a complaint after the paper suggested undisclosed/late-disclosed trials for Tresiba (insulin degludec).
Tresiba was first licensed and commercially available in the UK on 21 January 2013; the Second 2012 Code and Joint Position 2009 applied.
Novo Nordisk argued many Phase I/II and additional Phase III trials had no UK involvement (no UK sites/patients/investigators/funding; not run on behalf of the UK legal entity), so were out of scope of the UK Code.
For UK-involved Phase III trials, the Panel reviewed disclosure timing and accepted that some had approved delays/extensions; one trial (NN1250-3561) was disclosed late.

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Breach of Clause 13.1 (clinical trial disclosure) for trial NN1250-3561 due to late disclosure.
Breach of Clause 9.1 (high standards) due to the delay in disclosure.
No breach of Clause 2 (industry disrepute) because results had ultimately been disclosed.
No breach findings for other reviewed UK-involved Phase III trials (either disclosed within timeframe or had an approved extension), and no breach for trials with no UK involvement (out of scope).
No appeal.

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