Novo Nordisk: clinical trial disclosure for Ryzodeg – no breach (AUTH/2903/11/16) | PMCPA Case

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Key facts

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Case	AUTH/2903/11/16
Parties	Director v Novo Nordisk
Product	Ryzodeg (insulin degludec/insulin aspart)
Issue	Clinical trial disclosure (timeliness and scope)
Complaint received	06 December 2016
Completed	23 February 2017
Appeal	No appeal
Review	August 2017
Applicable Code year	2012
Clauses considered	13.1, 9.1 and 2
Decision	No breach
Panel notes on scope	Trials with no UK involvement were out of scope of the UK Code
UK-involved Phase III trials	NN5401-3594 and NN5401-3645
First approved/commercially available	21 January 2013 (Denmark)

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

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The PMCPA Director initiated a complaint after a CMRO publication (25 Nov 2016) assessed disclosure of results for company-sponsored trials linked to new medicines approved by EMA in 2013.
The publication’s supplemental data suggested that for Ryzodeg (insulin degludec/insulin aspart) nine evaluable trials (two Phase I/II and seven Phase III) had not been disclosed within the target timeframe; disclosure was reported as 61% at 12 months and 70% by 31 July 2015.
Novo Nordisk stated it was committed to transparency and that full clinical trial reports were available on novonordisk-trials.com.
Novo Nordisk argued most trials referenced had no UK involvement (no UK patients, investigators, centres, funding, and not conducted on behalf of Novo Nordisk Ltd, the UK legal entity), so were outside the UK Code’s scope.
For Phase III trials, Novo Nordisk stated only two studies had UK involvement (NN5401-3594 and NN5401-3645), both completed on 2 Dec 2010 (before first approval/commercial availability on 21 Jan 2013 in Denmark), meaning disclosure was due by 20 Jan 2014.
The Panel assessed scope (UK involvement) and whether disclosure occurred within the Joint Position timelines applicable under the Second 2012 Code (Joint Position 2009).

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No breach of the Code was ruled.
The Panel found Phase I/II trials had no UK involvement and were therefore out of scope of the UK Code.
The Panel found the two UK-involved Phase III trials had results disclosed by 20 Jan 2014 (within the required timeframe).
Remaining Phase III trials described by Novo Nordisk had no UK involvement and were out of scope of the UK Code.

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