AUTH/3236/8/19: Health professional v Merck Sharp & Dohme – incorrect Disclosure UK transfer of value entry | PMCPA Case

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Key facts

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Case number	AUTH/3236/8/19
Case reference	Information on Disclosure UK
Complainant	Health professional
Respondent/company	Merck Sharp & Dohme Limited
Product(s)	Not stated
Material/channel	ABPI Disclosure UK database (2018 transfers of value public disclosure)
Key issue	Incorrect public disclosure attributing a transfer of value/financial support to a named health professional who had not received it; repeat error and inadequate checking/cross-checking
Dates (received/completed if stated)	Complaint received 15 August 2019; Case completed 20 January 2020
Appeal	Related prior case AUTH/3141/12/18 was appealed by MSD on Clause 7.2; appeal unsuccessful (Appeal Board upheld breach of Clause 7.2). No appeal stated for AUTH/3236/8/19.
Code year	Not stated
Breaches/clauses	Breach: Clauses 2, 7.2, 9.1, 24.1. No breach (undertaking-related allegations): Clauses 29, 9.1 and 2.
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

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What happened

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A health professional complained about information on the ABPI’s Disclosure UK database, stating the 2018 disclosure included an incorrect entry indicating he/she received funding/financial support from Merck Sharp & Dohme (MSD).
The complainant had previously raised similar issues about MSD’s 2017 data, considered in Case AUTH/3141/12/18 (which MSD appealed).
The Panel identified incorrect material on Disclosure UK on 23 July 2019; MSD was notified on 26 July 2019 of the Panel’s rulings in the earlier case.
MSD stated the original error arose when an employee selected the wrong health professional in MSD’s internal system (two individuals had almost the same name, differing only by middle name), and the identifier then flowed through connected systems.
MSD described its transparency process, including internal systems, third-party data capture for meeting/congress support, internal review steps, and pre-disclosure verification letters/emails to health professionals/HCOs, followed by ABPI verification before publication.
MSD said it corrected the earlier (2017/ASCO-related) disclosure on 11 January 2019.
For the 2018 disclosure issue, MSD said it uploaded a corrected file to remove the incorrect data on 26 July 2019; the ABPI system supplier indicated the data was not removed in line with the usual timeframe and remained online for a further 10 days, with correction implemented on 13 August.
MSD listed corrective and preventive actions (CAPAs), including retrospective checks of submissions by the relevant employee, additional retraining and manager checks, duplicate-name checks across 2018 disclosures, two-person checks when multiple entries appear for the same name, guideline updates and retraining, internal audit review, and external expert review of processes.

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Outcome

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The Panel concluded that another incorrect disclosure had been published by MSD on Disclosure UK, attributing a transfer of value to an individual who had not received it.
The Panel ruled breaches of Clauses 24.1 and 7.2 because the published information was inaccurate and misleading.
The Panel ruled a breach of Clause 9.1, finding MSD failed to conduct comprehensive checks and cross-checks (particularly given the earlier complaint sent to the company in January 2019) and could have carried out further checks prior to submitting data to the ABPI.
The Panel ruled a breach of Clause 2, stating that a second inaccurate disclosure about a named individual reduced confidence and brought discredit upon the industry, and expressing concern about the undertaking wording given MSD’s knowledge that incorrect information was still present.
The Panel considered whether there was a breach of undertaking (Clauses 29, 9.1 and 2 in relation to the undertaking) and ruled no breach, because the undertaking relevant to the prior case was not given until 13 August and the second publication in June did not amount to a breach of that undertaking.
Complaint received: 15 August 2019. Case completed: 20 January 2020.

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Clauses

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Clause 2: Breach (publication of inaccurate transfer of value information for a second time; and concern about signing an undertaking without acknowledging knowledge of further incorrect publication).
Clause 7.2: Breach (published information on Disclosure UK was inaccurate and misleading).
Clause 9.1: Breach (failure to maintain high standards due to inadequate comprehensive checks and cross-checks).
Clause 24.1: Breach (incorrect disclosure of a transfer of value against an individual who had not received it).
Clause 29 (in relation to alleged breach of undertaking): No breach ruled.
Clauses 9.1 and 2 (in relation to alleged breach of undertaking): No breach ruled.

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AUTH/3236/8/19: Health professional v Merck Sharp & Dohme – incorrect Disclosure UK transfer of value entry

Key facts

What happened

Outcome

Clauses

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