Takeda: exhibition stand sponsorship linked to product advocacy; governance and due diligence failures (AUTH/2862/8/16)

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Key facts

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Case number	AUTH/2862/8/16
Parties	Anonymous, non-contactable complainant v Takeda
Issue	Engagement of a consultant and his/her training and consultancy company; grants for therapy reviews; sponsorship/exhibition stand; alleged inducement/switching
Complaint received	03 August 2016
Case completed	09 January 2017
Applicable Code year	2014 (October 2014 matters ruled under 2014 Code; 2015 matters considered under 2016 Code due to no significant differences stated)
No breach clauses	18.1, 19.1, 19.2, 21 and 23.1
Breach clauses	2, 9.1, 18.1 and 18.6
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

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

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An anonymous, non-contactable complainant alleged a specialist nurse (who also ran a training/consultancy company) delivered industry-funded audits/therapy reviews and training, and that this was linked to switching/irregular prescribing in local GP practices/CCGs.
Takeda had provided restricted-use grants in 2015 to support nurse-led clinics/therapy reviews at two GP practices/centres; both projects were subcontracted to the nurse’s consultancy company.
Takeda also paid for exhibition stand space at a one-day awareness course run by the consultancy company in October 2014.
An internal email (Oct 2014) between Takeda representatives described the nurse “convincing GP practices to switch” and suggested that, “in return” for funding support, the nurse would “advocate” and “help and support” Takeda’s product in primary care.
Takeda did not take adequate steps to ensure the exhibition stand payment did not exceed fair market value; senior staff copied on the email did not intervene effectively.
Separately, Takeda engaged the nurse as a speaker at two promotional GP practice meetings in Nov/Dec 2015 while the nurse/consultancy was contemporaneously delivering (non-promotional) therapy review services funded via Takeda grants.

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No breach was ruled for Clauses 19.1, 19.2 and 18.1 in relation to the 2015 restricted-use grants/therapy reviews because the complainant did not prove (on the balance of probabilities) that the arrangements amounted to a switch service or an inducement to prescribe.
No breach of Clause 23.1 was ruled regarding the nurse’s engagement to speak at two promotional meetings (insufficient evidence it was an inducement to prescribe).
No breach of Clause 21 was ruled (no evidence of relevant activity).
Breaches were ruled for the October 2014 exhibition stand sponsorship because the email created a link between funding and product advocacy/support, and fair market value was not adequately assessed.
Breaches were also ruled because Takeda failed to maintain high standards, including lack of due diligence around the nurse’s contemporaneous promotional and non-promotional roles.

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