AUTH/2866/8/16: Anonymous (non-contactable) v AstraZeneca – engagement of a consultant and training/consultancy company | PMCPA Case

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Key facts

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Case number	AUTH/2866/8/16
Parties	Anonymous, non-contactable complainant v AstraZeneca
Issue	Engagement of a consultant and his/her training and consultancy company; allegations of industry-funded audits/workshops and coercive funding pressure
Complaint received	03 August 2016
Case completed	03 January 2017
Applicable Code year	2014
Breach clauses	Clause(s) 9.1
No breach clauses	Clause(s) 2, 9.1, 18.1, 18.6, 21 and 23.1
Key Panel concerns	High-frequency engagements without evidence of required approvals; apparent FMV exceedance without justification/approval; poor control over payment authorisation (external party signed “approved by” line); insufficient due diligence/oversight given volume and perception risk
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal
Published	February 2017 Code of Practice Review

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

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An anonymous, non-contactable complainant alleged a therapy-area training and consultancy company (run by a health professional with NHS contractual roles and alleged prescribing influence) was funded by multiple pharma companies, including AstraZeneca.
Allegations included industry-funded “clinical audits” and accredited workshops leading to irregular use of sponsors’ products, and coercive behaviour (eg, threats that products would not be used unless funding was provided).
AstraZeneca stated it did not fund any clinical audits or the CCG-partnered accredited workshops alleged; it sponsored one stand/meeting run by the consultancy company in October 2014.
AstraZeneca engaged the named health professional extensively: 54 times as a speaker and twice as a chair at promotional meetings (May 2014–June 2016), plus 5 “Expert on Demand” virtual presentations in 2015.
Fees for services were paid to the training/consultancy company (per contracts), despite AstraZeneca describing the engagement as of the individual.
The Panel was concerned about governance: missing evidence of required written director approval for high-frequency engagements in 2016, apparent payments exceeding fair market value tables without documented justification/signatory approval, and a payment authorisation form for the October 2014 sponsorship being signed “approved by” the health professional (ie approving payment to themselves) rather than by the representative.

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Breach found: Clause 9.1 (high standards not maintained) due to poor control/due diligence over multiple engagements and non-adherence to internal SOPs.
No breach found: Clause 2; Clauses 18.1 and 18.6 (re October 2014 sponsorship); Clauses 21 and 23.1 (re speaker and Expert on Demand engagements); Clause 19.1 (no evidence AstraZeneca provided relevant medical/educational goods and services activity); and no evidence to support alleged inducement to prescribe.
The Panel noted the complainant provided no supporting evidence and could not be contacted for further detail; the complainant bore the burden of proof.

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