Public reprimand for Chiesi

• Date posted
  01 February 2015
• Sanction
  Public reprimand,
• Case number/s
  AUTH/2618/7/13 - AstraZeneca v Chiesi

In a case about the promotion Fostair, (Case AUTH/2618/7/13), Chiesi has been publicly reprimanded by the Code of Practice Appeal Board
for providing inaccurate information to the PMCPA both during the consideration of the case and at a subsequent audit.

In Case AUTH/2618/7/13, the Panel ruled a claim in breach of the Code but additionally noted a discrepancy between the presentation of the claim at issue in the material provided by Chiesi and the citation of that claim by the parties. Following notification of the Panel’s rulings, the complainant (AstraZeneca) provided a copy of the item at issue which showed the claim presented differently compared with the material provided by Chiesi. Before the PMCPA raised the matter with Chiesi, the company contacted the PMCPA and explained that an employee had changed the presentation of the claim after what should have been the final form, had been certified. This discrepancy had not been picked up by the company until it received the outcome of the Panel’s consideration of the case. Following this admission by Chiesi, the Panel asked for further details and reconvened to consider the matter. Upon receipt of more information the Panel noted Chiesi’s further admission that in its first undertaking, the date stated as being that on which the material was withdrawn was wrong; the material was actually withdrawn two weeks later.

The Panel reported Chiesi to the Appeal Board. On consideration of that report in October 2013, the Appeal Board noted Chiesi’s submission
that the failure to follow the correct approval process, and to recognise the difference between the approved leavepiece and the one that was distributed, and mistakes in its undertaking arose from human error and lack of attention to detail. In that regard the Appeal Board noted Chiesi had previously been censured for providing the PMCPA with inaccurate information (Case AUTH/2435/8/11) and it considered that Chiesi’s repeated failure in this regard was completely unacceptable. Self-regulation relied upon the provision of complete and accurate information by pharmaceutical companies. The Appeal Board was extremely concerned about Chiesi’s conduct and decided to require an audit of its procedures in relation to the Code and a subsequent re-audit.

The first audit was conducted in March 2014 and upon consideration of that audit report the Appeal Board noted that the company still had much work to do. In particular the Appeal Board was appalled that Chiesi had stated that a standard operating procedure had been updated when it had not. The Appeal Board considered that the further provision of false information to the PMCPA was completely unacceptable.

The second audit was conducted in October 2014 and upon its consideration of that report, the Appeal Board noted that progress had been made. The Appeal Board reminded the company that the provision of inaccurate information was completely unacceptable but on the basis that compliance plans were completed, progress continued to be made and the company’s focus on compliance was maintained, the Appeal Board decided that, on balance, no further action was required.