AUTH/2669/11/13: Member of the public v Shire – clinical trial disclosure for Resolor (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2669/11/13
Complainant	Anonymous, contactable member of the public
Company	Shire
Product	Resolor (prucalopride)
Issue	Clinical trial disclosure (alleged non-disclosure / disclosure outside timeframe)
Source prompting complaint	ABPI-funded transparency study published in CMRO (11 November 2013) with product-level data via linked website
Key dates (product)	First approved: 15 October 2009; first commercially available (Germany): January 2010
Key studies discussed	GBR-7; PRU-USA-8; PRU-INT-14; PRU-INT-17 (late 1990s); PRU-US-27 (US trial); M0001-C102 (Phase I healthy volunteers)
CMRO-linked metrics for Resolor	Total trials 26; unevaluable 4; evaluable 22; disclosed in timeframe 17 (77%); disclosed at all by 31 Jan 2013 for trials completed before end Jan 2012: 18/22 (82%)
Applicable Code year (PMCPA page)	2012
Panel’s applied framework	2008 Code and IFPMA Joint Position 2005 considered relevant for Resolor based on first approval/commercial availability timing
Clauses considered	Clause 2; Clause 9.1; Clause 21.3
Ruling	No breach
Complaint received	25 November 2013
Case completed	19 February 2014
Appeal	No appeal

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

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An anonymous, contactable member of the public complained about alleged non-disclosure of clinical trial results for Resolor (prucalopride), based on an ABPI-funded transparency study published in Current Medical Research & Opinion (CMRO) on 11 November 2013.
The CMRO study reviewed publicly available sources for trial registration/results disclosure (search window 27 December 2012 to 31 January 2013) across 53 new medicines approved by EMA (2009–2011). Product-level detail was provided via a linked website (not in the journal article itself).
For Resolor, the linked dataset reported 26 total trials, 22 evaluable, 17 disclosed “in timeframe” (77%), and 18 disclosed by 31 January 2013 for trials completed before end January 2012 (82%).
The complainant alleged breaches of Clauses 2, 9 and 21 of the Code (the case ultimately considered Clauses 2, 9.1 and 21.3).
Shire argued it was not in breach and explained the complex ownership/licensing history (Janssen/Ortho-McNeil → Movetis → Shire acquisition of Movetis in 2010) and contractual limits on access to historical trial information.
The Panel assessed which ABPI Code edition and which IFPMA Joint Position applied, focusing on whether results needed to be disclosed and the relevant timeframe.

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No breach of the Code was found.
No breach of Clause 21.3 (clinical trial disclosure) and therefore no breach of Clauses 9.1 and 2.
Four late-1990s studies did not require disclosure under the applicable Joint Position (2005) given Resolor’s first approval/commercial availability timing.
One US study (PRU-US-27) was found to be outside the scope of the UK Code for Shire (no UK involvement; completed before Shire purchased the product).
One Phase I healthy volunteer study (M0001-C102) was treated as exploratory; disclosure was considered preferable, but not required on the information provided.

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