Chiesi has breached the ABPI Code of Practice for the Pharmaceutical Industry and in addition has been publicly reprimanded
Chiesi has been publicly reprimanded for providing inaccurate information to the PMCPA during the course of a complaint about a leave piece and again during the course of a subsequent audit and is the subject of advertisements in the medical, pharmaceutical and nursing press.
Press Release 27 May 2015
Chiesi – Case AUTH/2618/7/13
For making a misleading and unsubstantiated claim about Fostair, Chiesi was ruled in breach of the following clauses of the Code:
Clause 7.2 – Making a misleading claim.
Clause 7.4 – Making an unsubstantiated claim.
The Code of Practice Panel ruled breaches of the Code and additionally noted a discrepancy between the presentation of the claim at issue in a leavepiece provided by Chiesi and the citation of that claim by the parties. Before the PMCPA raised the matter with Chiesi, the company contacted the PMCPA and explained that an employee had changed the claim after certification of what should have been the final form of the leavepiece. 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 noted Chiesi's further admission that in its first undertaking, the date on which the material was stated to have been withdrawn was wrong, it was actually withdrawn two weeks later.
The Panel reported Chiesi to the Code of Practice Appeal Board. In October 2013 when the Appeal Board noted Chiesi's submission that human error and lack of attention to detail led to 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 with the date in its undertaking. In that regard the Appeal Board noted Chiesi had previously been censured for providing 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. 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 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.
The full case report was published in the PMCPA February Code of Practice Review and is also available at www.pmcpa.org.uk. The public reprimand is also available on the website.
The advertisements will appear in the BMJ and The Pharmaceutical Journal on 28 February and The Nursing Standard on 4 March 2015.
Notes to Editors:
For more information please contact: Elly Button, 020 7747 8884, mobile 07920 863650.
The Prescription Medicines Code of Practice Authority (PMCPA; www.pmcpa.org.uk) was established by The Association of the British Pharmaceutical Industry (ABPI) on 1 January 1993 to operate the ABPI Code of Practice for the Pharmaceutical Industry at arm's length from the ABPI itself. The Code and other information, including details about ongoing cases and completed cases, is available at www.pmcpa.org.uk.
Complaints submitted under the Code are considered in the first instance by the Code of Practice Panel which consists of three of the following, the Director, Deputy Director, Secretary and Deputy Secretary of the Authority. One member of the Authority acts as the case preparation manager for a particular case and does not participate when the Panel considers that case. Both the complainant and the respondent company may appeal to the Code of Practice Appeal Board against rulings made by the Panel.
The Appeal Board is chaired by an independent legally qualified chairman. For the consideration of any case, independent members from outside the industry, including the Chairman, must be in a majority. Details of the Appeal Board's composition can be found on our website.