Bracco: rep lacked ABPI exam within timeline and device ad triggered PI requirement (AUTH/3265/10/19)

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Key facts

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Case	AUTH/3265/10/19
Parties	Complainant v Bracco UK Limited
Issue area	ABPI Medical Representatives Examination; prescribing information in advertising; high standards
Complaint received	16 October 2019
Case completed	13 February 2020
Applicable Code year	2019
Product/material	CTExprès syringe-less CT injector advertisement referencing Iomeron (iomeprol) on device display
Publication	RAD magazine (June, July, October; later also November issue stated by Bracco)
Breaches	Clause 4.1; Clause 16.3; Clause 9.1
No breach	Clause 16.1
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

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A named complainant alleged Bracco employed representatives to sell medicines without ABPI qualifications and cited a named representative who had not sat/passed the ABPI medical representatives examination within the required period.
The complainant provided a screenshot of an advertisement for the CTExprès syringe-less CT injector; the device display showed the medicine name Iomeron (iomeprol) but the ad did not include prescribing information.
The complainant also alleged a named member of staff did not appear to understand the Code.
Bracco said it assumed the representative already held the qualification due to prior pharma roles; the lack of qualification was discovered in early/mid-January 2018 during a routine inspection and processes were changed to require proof before employment.
Bracco said the representative’s role was primarily medical devices; the representative began promoting pharmaceutical products in February 2018 and ceased in late 2019; on receipt of the PMCPA letter Bracco stopped the representative from promoting pharmaceuticals.
Bracco argued the CTExprès journal ad (RAD magazine) promoted a medical device and the medicine name on the screen was incidental and not prominent; therefore it said the Code/PI requirement should not apply.

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Breach of Clause 16.3 (ABPI medical representatives examination not taken within the required timeframe).
Breach of Clause 4.1 (advertisement required prescribing information because a specific medicine name appeared).
No breach of Clause 16.1 (allegation that a named employee did not understand the Code was not supported by evidence).
Breach of Clause 9.1 (taking the rulings together, failure to maintain high standards).

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