Sunovion voluntary admission: late patient organisation disclosure and inaccurate information to PMCPA (AUTH/3027/3/18)

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Key facts

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Case number	AUTH/3027/3/18
Company	Sunovion Pharmaceuticals Europe Ltd
Case type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Topic	Working with patient organisations; disclosure of support; inaccurate information to PMCPA
Applicable Code year	2016
Key conduct	Late disclosure of 2016 patient organisation support; incorrect information provided to PMCPA; one activity proceeded without a written/certified agreement
Payments described	£10,000 (Oct 2016) admin/general running costs; £600 (Oct 2016) + £2,150 (Feb 2017) for early intervention guide (total £2,750)
Public disclosure timing	Website disclosure from 15 March 2018; amended 27 March 2018
Panel breaches	Clauses 2, 9.1, 27.7 (2016 payments)
No breach finding	Clause 27.7 (2017 payment)
Sanctions	Undertaking; public reprimand; audit; advertisement
Key dates	Voluntary admission received 16 March 2018; undertaking received 26 June 2018; Appeal Board consideration 13 September 2018 and 11 July 2019; interim case report first published 30 November 2018; case completed 11 July 2019

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

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Sunovion Pharmaceuticals Europe made a voluntary admission after it realised it had previously told the PMCPA (in comments on an audit report linked to Case AUTH/2935/2/17) that it had not worked with any patient organisations, which was incorrect.
In 2016 Sunovion entered into an arrangement with a registered charity supporting patients with mental health problems and made payments including:
- £10,000 in October 2016 for administration and general running costs (covered by a certified agreement).
- £600 in October 2016 and £2,150 in February 2017 (total £2,750) to support development of an early intervention guide for patients with schizophrenia and their families (no written agreement could be located).
Sunovion’s public disclosure about this support went live on its website on 15 March 2018 and was amended on 27 March 2018 (including correcting an initially misstated figure for the February 2017 payment).
The Panel considered the Code’s requirements for public disclosure of support to patient organisations and noted ambiguity about timing, but concluded the 2016 payments were not disclosed as required.
The Panel was concerned that Sunovion provided incorrect information to the PMCPA and that governance/controls appeared weak (including the absence of a certified agreement for one payment).

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Breach found: Clause 27.7 (in relation to both 2016 payments).
No breach found: Clause 27.7 (in relation to the 2017 payment, on balance, given the timing ambiguity and disclosure before the end of March the following year).
Breach found: Clause 9.1 (high standards not maintained, including activity proceeding without a certified agreement in place and late disclosure).
Breach found: Clause 2 (bringing discredit upon/reducing confidence in the industry due to incomplete/inaccurate information and poor governance).
Appeal Board imposed an additional sanction: public reprimand for providing inaccurate information to the PMCPA.
An audit took place in April 2019; by July 2019 the Appeal Board noted significant progress and decided no further action was required.

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