A Menarini voluntary admission: late Disclosure UK upload of 2016 R&D clinical trial payment (AUTH/2975/9/17)

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Key facts

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Case number	AUTH/2975/9/17
Company	A Menarini
Issue	Late disclosure of research and development (R&D) clinical trial payment(s) to a UK organisation
Applicable Code year	2016
Initial disclosure submission date	29 March 2017
Disclosure deadline	30 June 2017
Late upload date	21 August 2017
Portal integration confirmation	6 September 2017
Complaint received	30 August 2017
Voluntary admission received	31 August 2017
Completed	16 January 2018
Breach clause(s)	Clause 24.4
Sanctions	Undertaking received
Appeal	No appeal

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

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A Menarini made its initial, timely Disclosure UK submission for 2016 transfers of value on 29 March 2017.
After that submission, it received additional information from corporate/R&D colleagues about clinical trial (R&D) payments made to a UK organisation during 2016.
The additional R&D payment data was uploaded to the ABPI Transfer of Value Portal on 21 August 2017 (integrated on the portal on 6 September 2017).
The disclosure deadline for 2016 transfers of value was 30 June 2017 (first six months after year-end).
Under Paragraph 5.6 of the Constitution and Procedure, the PMCPA Director treated the voluntary admission as a complaint.

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Breach ruled for late disclosure.
The Panel found the disclosure deadline in Clause 24.4 had not been met because the data was not published within the first six months after the end of the calendar year in which the transfers of value were made.
The Panel disagreed with the company’s interpretation that “any submission of additional data after 30 June” would automatically be a breach; the key point was whether the data was published by the deadline (it was not).

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