AstraZeneca voluntary admission: contract rep arranged unapproved COPD patient reviews (AUTH/2322/5/10)

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Key facts

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Case number	AUTH/2322/5/10
Company	AstraZeneca UK Limited
Case type	Voluntary admission (treated as a complaint)
Issue	Contract representative arranged unapproved nurse-led COPD patient clinical reviews at another practice; mis-described as a speaker meeting; no written agreements/records; lack of transparency to patients
Therapy area	Chronic obstructive pulmonary disease (COPD)
Product mentioned	Symbicort (referenced in internal description of the proposed “COPD meeting”)
Patients reviewed	Approximately 30–40
Proposed payment	Approx. £300 (£20/hour); not paid and would not be paid
Complaint received	25 May 2010
Case completed	6 August 2010
Applicable Code year	2008
Breach clauses (final)	9.1, 15.2, 18.4
No breach clauses (final)	2 (on appeal), 14.1, 18.5
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A contract sales representative (working for AstraZeneca) verbally agreed that a practice nurse from one surgery would conduct COPD clinical reviews (approx. 30–40 patients) at another practice and train the resident nurse on findings.
The representative initiated this on his own initiative and outside AstraZeneca processes; there was no AstraZeneca review/approval of the service.
To obtain internal approval for spend, the representative submitted the activity as a “speaker meeting”/educational engagement and did not disclose that it involved patient clinical reviews.
The manager queried the proposed £300 fee; the representative justified it by claiming the nurse was influential and that extra time would be spent on “case studies”. The manager approved what he believed was a straightforward educational speaking engagement.
No written agreements existed between AstraZeneca and the nurse or the practice; AstraZeneca did not hold the protocol the GP believed he had seen.
No documents/records were generated or retained by AstraZeneca in relation to the service.
Patients were not told the nurse was sponsored by AstraZeneca (and the representative did not request such a declaration).
The nurse later contacted AstraZeneca for payment after she could no longer contact the representative; AstraZeneca investigated, made a voluntary admission, and stated it would not pay the fee.

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Treated as a complaint because it was potentially serious (patient reviews arranged without company knowledge).
Breaches upheld: Clause 9.1, Clause 15.2, Clause 18.4.
No breach: Clause 2 (on appeal), Clause 14.1, Clause 18.5.
Undertaking received (sanction).

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