AUTH/2987/10/17: Anonymous v Shire – Disguised promotion via market research email and MSL KPI concerns

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Key facts

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Case	AUTH/2987/10/17
Parties	Anonymous v Shire
Allegation theme	Alleged promotion prior to the grant of a marketing authorisation; disguised promotion via market research; MSL KPI concerns
Medicines referenced	Revestive (teduglutide); Natpar (rhPTH (1-84))
Key activities reviewed	Market research recruitment email; NICE/NHSE/CRG interactions; MSL performance goals/KPIs
Complaint received	25 October 2017
Case completed	31 July 2018
Applicable Code year	2016
Breach clauses	Clause 9.1; Clause 12.2
No breach clauses	Clause 2; Clause 3.1; Clause 18.1
Appeal	Appeal by respondent (Shire). Appeal succeeded on Clause 3.1/9.1 for the 6 Feb call/email; succeeded on Clause 3.1 for the 19 Jan meeting but Clause 9.1 upheld for poor documentation.
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous, contactable complainant (appearing to be an ex-employee) raised concerns about Shire’s communications with payers/KOLs and other stakeholders.
Three areas were investigated: (1) a market research survey email about Revestive (teduglutide), (2) interactions during NICE/NHSE processes relating ultimately to Natpar (rhPTH 1-84) pre-licence, and (3) Medical Science Liaison (MSL) visit targets/KPIs.
Market research (Revestive): A UK-based agency emailed 10 UK health professionals inviting participation in market research to test a managed entry agreement design and described Revestive as a “new product” and “important new treatment option”. The email was sent without Shire UK’s knowledge/consent and was not approved.
NICE/NHSE/CRG (Natpar): The complainant alleged pre-licence promotion and attempts to influence CRG clinicians and circumvent NICE. Shire described multiple interactions, many framed as responses to unsolicited requests and policy/budget planning discussions. The Panel initially found some pre-licence promotional breaches, but Shire appealed.
MSL KPIs: The complainant alleged MSLs had targets for number of visits linked to evaluation/bonuses, potentially encouraging proactive activity. The Panel reviewed Shire’s MSL Performance Goals and Objectives, including an “aspiration for KOL face-to-face interactions”.

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Breach found: Clause 12.2 (market research email was promotional and its promotional nature was disguised).
Breach found: Clause 9.1 (high standards not maintained) in relation to governance/controls around the market research activity commissioned at least in part internationally and executed via a third party.
Breach found (after appeal): Clause 9.1 for poor documentation/record-keeping of a face-to-face meeting (19 January 2017) with a CRG clinician (Natpar context). The Appeal Board overturned the associated pre-licence promotion finding but upheld the high-standards breach due to inadequate records.
Breach found: Clause 9.1 for inappropriate MSL KPI design (aspirational number-of-visits KPI linked to remuneration), which could encourage behaviour inconsistent with the Code.
No breach: Clause 3.1 (pre-licence promotion) was ultimately not upheld for the appealed Natpar items (19 January meeting and 6 February call/email). Other Natpar-related allegations were also not established on the evidence.
No breach: Clause 2 (particular censure) was not considered warranted.
No breach: Clause 18.1 (Panel stated the complaint did not raise a Clause 18.1 matter on the market research point).

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