AUTH/3265/10/19 - Complainant v Bracco

ABPI Medical Representatives Examination

  • Received
    16 October 2019
  • Case number
  • Applicable Code year
  • Completed
    13 February 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the Review

Case Summary

A named, contactable complainant stated that Bracco had employed representatives, without ABPI qualifications, to sell medicines. The representatives had been with Bracco for at least 3 years. The complainant alleged that Bracco had ignored the Code requirements in this regard. The complainant alleged that a named representative had not sat the ABPI examination within his/her first two years of being a representative.

The complainant provided a screenshot of an advertisement for CTExprès syringe-less CT injector which referred to Iomeron (iomeprol) on the display screen of the device and did not include prescribing information.

Finally, the complainant alleged that a named member of staff did not appear to understand the Code.

The detailed response from Bracco is given below.

The Panel noted that the representative worked as a representative prior to joining Bracco in a role where he/she would ultimately be promoting medicines as a well as medical devices. It was concerning that Bracco had not checked the position when employing the representative.

The Panel noted Bracco’s submission that the representative had not told the company that he/she did not have the examination.

The Panel noted Bracco’s submission regarding the dates the representative had sat the examination. As the full examination had not been taken within a year the Panel ruled a breach of the Code.

The advertisement provided by Bracco was A3 in size and focussed on CTExprès, a syringe-less CT injector. The advertisement claimed ‘user friendly’, ‘faster patient throughput’, ‘Optimizes patient-tailored dosing to reduce waste’ as well as reductions in consumable costs, contrast media usage and clinical waste costs. The illustration included 2 reservoirs labelled ‘contrast media’. The display indicated that these were Iomeron 482mL.

The Panel considered that the inclusion of a product name on the display meant that the prescribing information was required and the failure to do so was ruled in breach of the Code.

With regard to the allegation that a named employee did not appear to understand the Code, the Panel noted that the Constitution and Procedure for the PMCPA stated the complainant had the burden of proving his/her complaint on the balance of probabilities. All complaints were judged on the evidence provided by the parties. The complainant had provided no evidence to support his/her allegations. The Panel therefore ruled no breach of the Code.

The Panel considered that when taking the rulings together, Bracco had failed to maintain high standards and thus a breach of the Code was ruled.